 |
BioQuality Current and Back Issue Contents
[All issues have summaries
of recently-reported 483 citations; regulatory |
2010
| Date | Vol. (No.) | Feature Article(s) | Meeting Notes | Other Feature(s) |
| January 2010 |
15(1) |
2009—Bad Economy=Jobs Lost + Record Fund Raising |
Biotech Approvals up for the Third Year, A Decade of FDA Form 483 Notices of Deficiency |
|
| February 2010 |
15(2) |
Which Way, FDA? |
Cord Blood Licensure: A Workshop |
Road Map to 2015, Happy Crystal Anniversary EMA, New Approvals , Safety News , ICH Happenings Invitation to Learn |
| March 2010 |
15(3) |
Comparability Studies—Still a Scientific Art Guidances are Helpful, but not the Whole Story |
Blood Products Advisory Committee; Notice of Meeting; Food and Drug Administration and Process Analytical Technology for Pharma Manufacturing: Food and Drug Administration--Partnering With Industry; Public Conference. |
FDA Issues Unwanted Immunogenicity Guidance, Health Canada Releases Final Guidance on Generic (Subsequent Entry) Biologics, Components of Extraneous Virus PCV1 in GSK’s Rotavirus Vaccine Rotarix |
| April 2010 |
15(4) |
The Cost of Non-Compliance: CGMP Problems at Genzyme |
Genzyme’s Replies: What Went Wrong?, First Cancer Vaccine Achieves Marketing Status |
|
| May 2010 |
15(5) |
Q and A with the Regulators: Part 1 of a 3-Part Series |
The 13th Annual Food and Drug Administration- |
US Finally Gets Approval Pathway for Generic Biologics |
| June 2010 |
15(6) |
Q and A with the Regulators: Part 2 of a 3-part Series |
Developing Guidance on Naming, |
|
| July 2010 |
15(7) | |||
| August 2010 |
15(8) | |||
| September 2010 |
15(9) | |||
| October 2010 |
15(10) | |||
| November 2010 |
15(11) | |||
| December 2010 |
15(12) |
2009
| Date | Vol. (No.) | Feature Article(s) | Meeting Notes | Other Feature(s) |
| January 2009 |
14(1) |
2008 : Product Safety, and the Slowing Economy Although the Industry Remains Strong—Jobs are Fewer |
483 Summaries for Eleven Years CBER Leads Year for Approvals with Seven BLAs; CDER Comes Close with Five BLAs Review of 483 Notices of Deficiency from 2008; Inadequate Investigations and Validation are Most Frequent Categories |
|
| February 2009 |
14(2) |
QbDA-New Concept for the QC Lab? Or Back to the Future? |
EU and US Approve Products; Genentech’s Raptiva Linked to 3 PML Deaths; Acting FDA Commissioner Takes Office January 20, 2009 |
|
| March 2009 |
14(3) |
Genzyme Receives Two FDA Letters in One Day: |
Industry Exchange Workshop on Food and Drug Administration Drug and Device Requirements: Public Workshop. |
GMP Deficiencies in Genzyme Warning Letter and Problems with Their Response; Human Cell & Tissue and Cellular & Tissue-based Products (HCT/P) Inspections ; Numbers Leveling out and Hours on Site Heading Back Down |
| April 2009 |
14(4) |
GAO Stings Coast IRB, LLC and HHS in IRB Investigation |
The 12th Annual Food and Drug Administration-Orange County Regulatory Affairs Educational Conference; “Regulatory Affairs: The Challenges of Ensuring Product Safety”.; Preparation for International Conference on Harmonisation Meetings in Yokohama, Japan |
Chapter <1033> Bioassay Validation Appears in PF; FDA Issues 17 Warning Letters the First Half of April FDA Issues Two Warning Letters to Chinese Facilities |
| May 2009 |
14(5) |
Margaret Hamburg, MD, New FDA Commissioner Activist Commissioner Indicates More Interesting Future |
Transmissible Spongiform Encephalopathies Advisory Committee; FDA Clinical Trial Requirements; Public Workshop |
FDA Changes Its Web Page…...Again |
| June/July 2009 |
14(6) |
Biosimilars and Follow-on Proteins: How Similar and What Follows? |
Food and Drug Administration Transparency Task Force; Public Meeting |
FDA Launches Transparency Blog |
| August 2009 |
14(7) |
Comparability of Clinical Material: QbD and Clinical Experience |
Vaccines and Related Biological |
Survey on Quality Systems Used for Bioanalytical Analysis GLP and GLP-Like are Systems of Choice |
| September 2009 |
14(8) |
Practical Applications of Quality Risk Management (QRM) |
Industry Exchange Workshop on |
2009 PDA Cell Substrate Workshop, Bethesda, MD, July 29-30, 2009 |
| October 2009 |
14(9) |
Regulatory Challenges of Manufacturing Changes for Combination Products: An FDAer’s View |
Food and Drug Administration Transparency Task Force; Public Meeting; Request for Comments |
|
| November 2009 |
14(10) |
BioAssay Conferences: Technical and Regulatory Info- |
Vaccines and Related Biological |
H1N1 Vaccine: Regulatory and Technical Issues Explained to Congress |
| December 2009 |
14(11) |
2008
| Date | Vol. (No.) | Feature Article(s) | Meeting Notes | Other Feature(s) |
| January 2008 |
13(1) | Europe Regulatory Scene Sees Many Changes in 2007 |
Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting; Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting |
CBER leads the pack with seven BLA approvals in 2007, EMEA has six MAA while CDER only approves 2 NCE BLA products; Ten Year and Eleven Year Reviews of EU and US GMP observations during inspections. Compare and contrast; Top three GMP Observations for US: Failure Investigations, Equipment/Validation and Validation presented in detail. |
| February 2008 |
13(2) |
Ins and Outs of Quality by Design: Industry Meeting Focuses on QbD |
Recombinant Thrombin approved in spite of protests from sponsor of bovine product.; Japanese and US inspection results; Update on Baxter’s Heparin Safety Issues. API is current suspect. |
|
| March 2008 |
13(3) |
Heparin Investigation Continues |
EMEA Stands Tough on Negative Opinions,Dropping Sterility Testing From Stability Programs, Guidance Recommends other Container/Closure Integrity Tests, American Red Cross to pay 4.6 Million Dollars to FDA |
|
| April 2008 |
13(4) |
What is in a Name? BioSimilar or FOPPs? Or...We Have Met the NME and He is Us? |
Blood Products Advisory Committee; Notice of Meeting. Fed Reg. March 26, 2008; 73(59): P. 16023 Location: Hilton Hotel, Washington DC/Rockville Executive Meeting Center, 1750 Rockville Pike, Rockville, MD 20852. Contact: Donald W. Jehn or Pearline K. Muckelvene, CBER, 301-827-0314 Meeting on May 1, 2008 and May 2, 2008 |
Anti-TNF Antibody Product Approved for use In US |
| May 2008 |
13(5) |
Office of Enforcement Issues 3 Warning Letters in 3 Months |
Vaccine Industry Receives Tough FDA Oversight; Bullet Point Summary of Merck Warning Letter; Novartis Vaccine Manufacturer Also Faces FDA Warning Letter |
|
| June 2008 |
13(6) |
BioPharma All Grown-Up and Growing Slower |
FDA Slaps ARC Wrist…..Again….The Bill? 1.668 Million USD |
|
| July 2008 |
13(7) | It’s Official….Part 211 No Longer Rules...for Phase I FDA Finalizes Rule to “Regulate” Phase Under |
Rapid Methods for Detecting Mycoplasma Contamination in the Manufacture of Vaccines, Including Pandemic Influenza Vaccines, and Other Biological Products; Public Workshop. | Phase 1 CGMPs Focus on Aseptic Processing; Bullet Point Summary of the “CGMP for Phase 1 Investigational Drugs” Guidance |
| August 2008 |
13(8) |
Quality by Design for Biotech Products & Processes Quality Attributes are Product Attributes |
Blood Products Advisory Committee; Notice of Meeting, Risk Communication Advisory Committee; Notice of Meeting, Achieving a Future Vision at the 2008 Parenteral Drug Association and the Food and Drug Administration Joint Regulatory Conference. |
Tysabri and PML are Back in the News |
| September 2008 |
13(9) |
BioShield Funding Still Going Strong in 2008? |
Preparation for International Conference on Harmonization Meetings in Brussels, Belgium; Public Meeting Structured Product Labeling Content of Labeling and Electronic Drug Establishment Registration and Drug Listing for the Biologics Industry; Public Workshop |
cGMP Final Rule to Be Implemented December 2008 |
| October 2008 |
13(10) |
GAO Cites Problems with FDA’s Foreign Inspections |
2008 PDA/FDA Conference: Harmonization, Implementation and Modernization: FDA admits it can not do it all; FDA Upgrades Their Inspection Team |
|
| November 2008 |
13(11/12) |
FDA Releases FY2007 Data for Reviews and Enforcements |
Immunogenicity of Therapeutic Proteins Questions and Controversies Still Abound; US Marshals seized 11 lots of heparin ; FDA Enforcement Statistics for 2007 |
|
| December 2008 |
13(12) | See Above, Nov/Dec Combined |
2007
| Date | Vol. (No.) | Feature Article(s) | Meeting Notes | Other Feature(s) |
| January 2007 |
12(1) | 2006: Year in Review- The Year of the Biosimilar 11 New Products Approved Amid Concerns of Product Safety | Industry Exchange Workshop on Food and Drug Administration Clinical Trial Requirements | Ten Year Look at 483 Trends- top three observations are validation, failure investigations and record keeping, Cleaning, Process and Analytical Validations prove to be the most problematic, Sterility Failure Investigations cause the most problems. |
| February 2007 |
12(2) | EMEA Reveals GMP Inspection Results 1995-2005 Deficiencies Categorized | Sentinel Network to Promote Medical Product Safety | EMEA Releases Quality Defects Report, Top 20 EMEA GMP Deficiencies: Non-Critical |
| March 2007 |
12(3) | Post-Approval Changes—to Change Again? FDA Seeks Input on Potential Changes to 314.70 | Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting. Fed Reg. March 5, 2007 | Today’s Problems. Tomorrow’s Solutions: WCBP Session Discusses Where We have been and Where we are Going, EMEA Issues Annual Report for 2005: Numbers for Applications; Inspections and More; Get Out and Stay Out! Advice from WCBP on Outsourcing Analytical Methods |
| April 2007 |
12(4) | GAO Suggests Increasing FDA’s Post Approval Authority Are Post Approval Drug Safety Studies on the Horizon? |
THE 10TH ANNUAL FDA-ORANGE COUNTY, REGULATORY AFFAIRS
EDUCATIONAL CONFERENCE Preparation for ICH Meetings in Brussels, Belgium |
Passing Your FDA Inspection with Flying Colors: Helpful Tips from Your Friendly FDA Investigator; EMEA Issues Annual Report for 2006—More and Less of Everything :More Approvals, More Applications, Shorter Review Times |
| May 2007 |
12(5) | EMEA Releases First-in-Man Clinical Guidance Focus on Non-Clinical and Clinical Trial Designs | EMEA releases drug development report-detailing a wish list of approaches; FDA budget introduces user fee and more money for post-approval drug safety surveillance; EMEA approves first accelerated product; First Bird Flu Vaccine in the US is approved | |
| June 2007 |
12(6) | Another Flu Vaccine Manufacturer Receives Warning Letter MedImmune UK Facility Cited for GMP Problems |
Anthrax Vaccines-Bridging Correlates of Protection
in Animals to Immunogenicity in Humans; Public Workshop. Meeting on
Nov. 8-9, 2007 Hilton Washington DC North/Gaithersburg, 620 Perry Pkwy.,
Gaithersburg, MD, Contact Person: Pier Minor
Cellular, Tissue and Gene Therapies Advisory Committee; Notice of
Meeting. Fed Reg. June 19, 2007; 72(117): P. 33764] Meeting on July
26, 2007 NIH Bldg. 29B, Conference rms. A/B, 9000 Rockville Pike,
Bethesda, MD |
MedImmune Warning Letter: Failure Investigation, Aseptic Processing and Cleaning; FDA Issues Final Influenza Vaccine Guidances -Clinical Data Requirements; EPO Biosimilars granted marketing authorization. See Regulatory Update |
| July 2007 |
12(7) | Workshop on First-in-Man Clinical Trials Garners Criticism More Risk Mitigation and Fewer Definitions? |
FDA reissues updated guidance for cooperative manufacturing arrangements.; EU says no to Tysabri for treatment of Crohn’s Disease; ICH issues Q10 outlining pharmaceutical quality systsems; FDA issues guidance on the Integrated Summary of Effectiveness and Integrated Summary of Safety | |
| August 2007 |
12(8) | Death in Targeted Genetic’s Clinical Trial Rocks Industry Clinical Trial on Hold Pending Cause of Death Reports |
EMEA approves MDCK Fermentation Flu Vaccine. This represents the first non-egg production process for seasonal flu; EMEA discusses PAT and QbD for biologics; EPAR provides details for approved Pegylated EPO. The EPAR is now available on the Web | |
| September 2007 |
12(9) | Report Card for Team Biologics The Good, the Bad and the Citations |
Mylotarg fails to gain marketing authorization in Europe. See In the News: European Round up, Special 483 Inspection Results ; Categorized bullet point summaries from MedImmunes 2007 Inspection! | |
| October 2007 |
12(10) | Congress Approves New Legislation Drug User Fees: Yes — Biosimilars: No |
Educational Workshops on Current Good Manufacturing Practices; Public Workshops. | Summary of Follow-on Biologic Legislation in Congress
GAO Slams Bioshield. Blame falls on government and small biotech company |
| November 2007 |
12(11) | Biopharmaceutical Economics—Good or Bad? |
Vaccines and Related Biological Products Advisory Committee; Immune Correlates of Protection Against Influenza A Viruses in Support of Pandemic Vaccine Development |
First product approved with required medical guide. The second generation small pox vaccine is approved; Mark McClellan to chair new Reagan-Udall Foundation; Europe returns negative opinions on two potential Crohn’s Disease therapies; DNA Plasmid Vaccine Guidance issued by FDA—some test requirements are dropped |
| December 2007 |
12(12) |
Round One of Changing the US CGMPs |
CGMP Proposed Rule Changes in succinct bullet points.; rhThrombin attempting an abbreviated approval pathway? Judge for yourself.; ICH Step 2 guideline issues from Pharmacoepial Disscusion Group. |
2006
| Date | Vol. (No.) | Feature Article(s) | Meeting Notes | Other Feature(s) |
| January 2006 |
11(1) | Drug Safety and Lack of New Proucts – 2005
hot topics Studies Indicate no Change in Safety Profiles |
New Products: The Few and Far Between CDER Approves only 1 New Biotech Product in 2005 EMA Publishes Annex 19 for Sampling Reference and Retention Samples for starting materials, packaging and final product |
|
| February 2006 |
11(2) | Part 211 No Longer Applies to Phase 1 Trials. FDA Issues Guidance for GMPs During Development | Blood Products Advisory Committee, Vaccines and Related Biological Products Advisory Committee | First BioSimilar Product Approved in Europe, Bullet Point Summary of Phase 1 of FDA’s GMP Guidance, First Inhalation-Insulin Product Approved |
| March 2006 |
11(3) | Regulatory and Analytical Updates for BioPharma. Drug Safety and Potency Assay are Big Topics | Systems inspections for API, Immunogenicity cited as reason for failed marketing authorization by EMEA, Reference Material and Potency | |
| April 2006 |
11(4) | Multiple Review Cycles versus Single Review Cycles. Achieving approval the first time. FDA issues a report with some clues | Industry Exchange Workshop on FDA Clinical Trial Requirements; Public Workshop, The Ninth Annual FDA-Orange Country RA Educational Conference | BioPharmaceutical System Inspections: its official now! FDA issues a CPGM outlining the nuts and bolts of how it is done, EMEA Issues Immunogenicity Concept Paper. They stress assays, prediction and risk management |
| May 2006 |
11(5) | Information about First Approved Biosimilar Available EMEA Posts Scientific Discussion Documents on the Web
|
GAO Highly Critical of FDA’s drug safety program, EMEA Grants First Conditional marketing authorization, FDA Continues Confidentiality agreement with EMEA, Approval and Development Details behind the recent Myozyme approval in both the US and EU | |
| June 2006 |
11(6) | MHRA Releases Summary Report on TGN1412 No GMP, GCP or GLP Problems Found |
FDA Withdraws Multiple gudances. ICH is in—FDA guidances are out, EMEA Issues GCP Inspection results for TeGenero Clinical Study, European groups issue roadmaps delineating potential future tasks. | |
| July 2006 |
11(7) | CBER Issues Sanofi-Pasteur a Warning Letter Sterility and Failure Investigations focus of Inspection |
Industry Exchange Workshop on Food and Drug Administration
Clinical Trial Requirements; Public Workshop (Notice of public workshop).
Fed Reg. June 8, 2006; 71(110): P. 33311
Workshop on August 23, 2006 and August 24, 2006. The Northland Inn,
7025 Northland Dr., Brooklyn Park, MN 55428. Amy Johnson 612-758-7131 |
FDA Comes Under Congressional Scrutiny for Lack of Warning Letters . Representative Waxmen releases critical report, Genentech Gains Product Approval but still has those pesky HADA assays to develop, Negative Opinion for Biosimilar, seems they need to pay more attention to their impurity profiles |
| August 2006 |
11(8) | ARC Redux | Transmissible Spongiform Encephalopathies Advisory Committee. Meeting on September 18, 2006. The Holiday Inn Gaithersburg, Two Montgomery Village Ave, Gaithersburg, MD. William Freas | American Red Cross- Not a New Player in Non-Compliance, FDA’s Continuous Marketing Application Pilot Program |
| September 2006 |
11(9) | BioSimilar by any other Name…Does it Smell As Sweet? INN Naming Conventions Cause Uproar | Preparation for International Conference on Harmonization
Meetings in Chicago, Illinois; Public Meeting. Fed Reg. August 17, 2006;
71(159): P. 47500 Docket No. 2006N-0312 Meeting on October 2, 2006,
5600 Fisher Lane, 3d.Fll, Conference Room G, Rockville, Md; Tammie Bell
301-827-0919 Conduct of Emergency Clinical Research; Public Hearing. Fed Reg. August 29, 2006; 71(167): P. 51143 Docket No. 2006D-0331 Hearing on October 11, 2006 Comments due November 27, 2006, University System of Maryland Shady Grove Center, 9630 Gudelsky Dr., Rockville, Md; Terrie Crescenzi 301-827-7864 |
FDA Fines ARC— The Price Tag? 4.2 Million Dollars, CDER Inspection Update: CDER Facts |
| October 2006 |
11(10) | IOM Issues Long Awaited Safety Report FDA Commissioner Appointment for Six Years? | Perspectives on Warning Letters: A History Lesson; EMEA’s increased applications causes budget concerns for 2007 | |
| November 2006 |
11(11) | BioGeneric Bill Introduced into the House: A Legal Pathway for BioGeneric? Soon? | Requirements for Foreign and Domestic Establishment Registration and listing for Human Drugs, Including Drugs Regulated Under a BLA, and Animal Drugs; Public Meeting; Extension of Comment Period (Pro-posed rule; Fed Reg. Oct 31 2006; 71(210): P. 63726 Meeting on December 11, 2006 Comments due January 26, 2007; FDA, Center for Drug | Approval Information: EMEA vs. FDA– EMEA improves and FDA worsens; FDA’s Freedom of Information lags behind in response time and denies news media legal waivers; Analytical Methods for Approved Vaccine Product—Bullet Point Summary |
| December 2006 |
11(12) | Expanded Access to Investigational Drugs Sound like a Tier-1 Approval System? Close but not Quite. |
EMEA approves first Mock-up Pandemic Vaccine, Final Guidance Issued for Gene Therapy Products. Fifteen Year follow-up required for certain products, PIC/S Holds First Industry Forum and agree to communicate better about their training schedule, GAO Issues Critical Report about FDA’s DTC Practices. They want better accountability |
2005
| Date | Vol. (No.) | Feature Article(s) | Meeting Notes | Other Feature(s) |
| January 2005 | 10(1) | EMEA Issues a Guidance for Biosimilar Molecules | 2004 – A Systematic Year: Full of Risk Assessments
and a New Inspectional Paradigm 2004 In Review: Product Approvals |
|
| February 2005 | 10(2) | European Inspection Results – Top 10 Observations | What’s in the Pipeline? | |
| March 2005 |
10(3) | The Process of Process Validation: Sometimes Three, Sometimes Less and Sometimes More | Two More CBER Products ICH Q8 – Guidance on Pharmaceutical Development Effects of New Drug Safety Oversight Board |
|
| April 2005 |
10(4) | BioSimilar? BioGeneric? Follow-on Biologic? BioSimilar Takes the Lead | FDA Issues Risk Management Guidances: Focus Remains
Clinical and not Analytical EMEA’s BioSimilar Guidance Issued Senate Hears About Drug Safety and Considers Better Post-Marketing Surveillance |
|
| May 2005 |
10(5) | Faster and Faster…..Development Acceleration Surrogate Endpoints and BioMarkers | ARC Receives Adverse Determination Letter – Their Bill
this Time? $540,000.00 Coming Soon to a Web Page Near You…..Drug Watch FDA Tells You that Less is Okay? |
|
| June 2005 |
10(6) | Special Inspection 483 Issue – Six Months of the Most Recent Observations – Together in One Issue | cGMPs at a Glance | |
| July 2005 |
10(7) | PDUFA Report Reveals Interesting Trends – What About Refusals-to-File Rates? | EU Issues Biosimilar Guidelines BIMO Warning Letters ICH Q) – Risk Management and the Quality Group |
|
| August 2005 | 10(8) | EMEA Reviews 5 Years of Orphan Drug Approvals – Even Super Orphans are Available | TSE in Raw Material – Still a Resourcing Issue | Making Money with Orphan Biotech Products |
| September 2005 |
10(9) | DDMC’s Warning Letters Spark the Old Debate WLF Throws Down the Gauntlet | Product Approvals, Chiron’s Inspections and More | |
| October 2005 | 10(10) | “Vegetarian” Manufacturing Processes Beware! | Details of the Mycoplasma Contamination in Plant Derived TSB | |
| November 2005 |
10(11) | FDA Sued Over Public Access to Invetigational Drugs – Patients Claim FDA is Taking Over their Constitutional Right to Life | Validation and Compliant Handling Court Decision Allows Increase Flexibility | |
| December 2005 |
10(12) | Drug Safety: Safe Enough? Approved Fast Enough? FDA Pulled in Many Directions by Many Special Interest Groups | Inspection Results for 2005 – No News is Good News? Everything Changes, but it all Stays the Same |
2004
| Date |
Vol. (No.) |
Feature Article(s) |
Meeting Notes |
Other Feature(s) |
| January 2004 | 9(1) | Recap of Last Year’s Regulatory Trends The Nelson Ratings of FDA Happenings | A Dozen Products Approved in 2003No New Enforcement Trends During 2003Warning Letters in 2003: General Counsel Gone and Voila: a GMP Warning Letter | |
| February 2004 | 9(2) | Setting Specifications – a Science? Or a Game of Name that Number? | Team
Biologics in the 21st Century? Annual Product Reviews Become Mandatory in the EU World Update |
|
| March 2004 |
9(3) | Coming May 1: Major Change in Product Quality Requirements for European Clinical Trials! | American
Red Cross Fails at Failure Investigation McClellan’s Nomination to Head CMS Wreaks Havoc in Commissioner’s Office |
|
| April 2004 |
9(4) | EMEA and FDA Issue Pie in the Sky Future Plans; Slow Product Pipeline; Additional Member States | Quality
Paradigm for Clinical Samples: GCP vs. GLP vs. GMP Fast Track Races On |
|
| May 2004 |
9(5) | Trials and Tribulations: EU Clinical Trials Directive: Without Much Fanfare Directive Takes Effect | BQ
Criticized in Notice to Industry to Wake up and Take Charge: Industry
Representatives Should Actively Develop Their Own Quality Standards More MRA’s, No More CPMP and a Few Other Things Risky Business: FDA Issues First “Risk” Guidances |
|
| June 2004 |
9(6) | If You’ve Got the Time, We’ve Got the Update: Team Biologics, cGMPS for the 21st Century and More | Top
10 GMP Deficiencies Pre-Approval Inspection Problems After the Inspection, after the Champagne, The Finishing Touch to Achieving Compliance |
|
| July 2004 |
9(7) | Vaccine Cell Substrates: What’s New in 2004 | Team
Biologics Inspection Results: Gradual Improvement Means more VAI and
Fewer Warning Letters Changing Cell Substrates for an Approved Product |
|
| August 2004 | 9(8) | Follow-on Biologics….a Rose by Any Other Name….Generics in our Future or Star Crossed Lovers? | Goodbye Three Batch Validation? So it goes for Drugs but not Biotech Drugs! | |
| September 2004 | 9(9) | They Have a Statute and They’re Not Afraid to Use It: Phase 1 Clinical Trial Manufacture to be Removed from 210/211 | Guidance
for GMPs During Development – Preview Systems Inspections for Biotech Products Big GMP Initiative Announcement? |
|
| October 2004 | 9(10) | Big News? Where is the Fanfare? cGMPs for the 21st Century Final Report Issued | FDA
Meets ISO: Mounds of Paperwork! New FDA Website Resource: Q&A on cGMP for Drugs Quality Systems and the cGMPs |
|
| November 2004 | 9(11) | Designing Stability Studies Rationally and Scientifically: More Time Points – And Averaging OOS Results? | Case
Study: How Not to Handle an OOS Result Validation of a Rapid Sterility Test for Cell Therapy Products |
|
| December 2004 | 9(12) | Inspection Results for Chiron’s UK Facility Available: MHRA and FDA Inspection Results Included in this Issue | Chiron’s MHRA Inspection Results and Replies |
2003
|
Date |
Vol. (No.) |
Feature Article(s) |
Meeting Notes |
Other Feature(s) |
| January 2003 | 8(1) | Choice of End-Point May Decide Who Wins. Genzyme and TKT Face off in an Approval Show Down | Recent Pre-Approval Inspectional IssuesIn With the New and Out with the Old; Update of the CBER to CDER "Consolidation" | FDA Halts an Additional 27 Gene Therapy Clinical Trials; Another X-SCIDS Patient with Leukemia |
| February 2003 | 8(2) | Tenderfoot Commissioner Rolls Out His Plan: Decreasing Review Cycles and Improving Communication | BioMarin Receives a Complete Response LetterGuidance Issues for the Common Technical Document: CMC SectionDocument Control for Regulatory Agency Inspections | |
| March 2003 | 8(3) | Part 11 First Major Target of the GMP Initiative | cGMP Initiative Addresses Inspectional Issues; 483s, Warning Letters, Role of Product SpecialistsClinical Holds for Gene Therapy Trials Reconsidered | |
| April 2003 | 8(4) | Increased Refusals to File in Our Future? Several FDA Sources Hint this is the New Panacea | Successful Comparability Does Not Just Happen! | |
| May 2003 | 8(5) | New and Better cGMPs; Lots of Talk, but Little Action | Forward into the Past? Self-Regulating and First Party Audits the Difference is?Genzyme Wins Approval for Two Products | |
| June 2003 | 8(6) | Regulatory Changes in Europe: More Centralized Review. More Shared Inspections | PIC/S to Start Sharing Foreign Inspection ReportsFDA And ARC at it AgainGuidance for Industry: INDs for Phase 2 and Phase 3 Studies | |
| July 2003 | 8(7) | Analytical Conference Highlights Strengths; But Remember Not All Changes are Created Equal | Rolling Submissions are Back and All Grown UpUn-Vitro - In Vivo Correlations Heading for the Big Time? Dissolution Testing Not Just for Oral Dosage Forms | |
| August 2003 | 8(8) | Team Biologics in Review; The Death Toll or You've Come a Long Way Baby? | Team - How They Have Been!CMC Meeting Discusses Method Qualification vs. ValidationGuide to the Guidances: Qualifying or Validating? | |
| September 2003 | 8(9) | First Anniversary of the cGMP Initiative: Details of a New Pharmaceutical Inspectorate Emerge | Combination Biopharmaceutical/Device Products: Two is Not Necessarily Better Than One | Red Cross and Amgen Targets of FDA NoticesComparability Guidance Provides Standard Advice |
| October 2003 | 8(10) | Steps Toward Globalization? EMEA and FDA to Share Data | Quality Management: A Company-Wide Commitment! | CDER Announces Reorganization for Biotech |
| November 2003 | 8(11) | GMPs for Clinical Supplies Now Mandatory in EU : Both EMEA and the US Fiddle with GMP Requirements | Building an Effective 'Quality Vision' | EU Update: Rappateurs Rate Dossier QualityFDA Update: FDA Issues Guidances and More Guidances And.. the American Red Cross and FDA Act 2 |
| December 2003 | 8(12) | ICH6 Conference: Regulatory Agency Comfort with the ICH Process and a New Biotech Product Comparability | CryoLife Continues to be Object of FDA's Attention |
2002
|
Date |
Vol. (No.) |
Feature Article(s) |
Meeting Notes |
Other Feature(s) |
|
January, 2002 |
7(1) |
Recap of Last Year's Regulatory Trends - Popular Press News Impacts Biopharmaceuticals |
|
CBER Approves Eight New Therapeutic BLAs in 2001Inspections Results for 2001 - Not Many Surprises |
| February, 2002 | 7(2) | Communication with the FDA: Face-to-Face and Not Blowing It | The American Red Cross and FDA in Court AgainAssessment of TSE Exposure for Low Risk Materials | |
| March, 2002 | March, 2002 7(3) | ICH Q7A: It's a Bird...It's a Plane...It's Super Guidance! | One Orphan After Another | |
| April, 2002 | 7(4) | Hints into the European Compliance Scene | Major Compliance Issues with European Marketing LicensesWhens, Whys, and Wheres of GMP Regulations 'Round the Globe | |
| May, 2002 | 7(5) | Aseptic Processing and Environmental Monitoring: Challenges Without Guidances | Consent Decrees - An Experience Not Easily Forgotten | More Details on the Common Technical DocumentEndotoxin Measurement: No Joking Matter |
| June, 2002 | 7(6) | Manufacturing Changes and Product Comparability: The View After five Years | Changes Keep On Changing - ORA Under PressureCBER's Comparability Experience-Specified Products | Genetch to Pay $300 Million |
| July, 2002 | 7(7) | Biologics Regulations-The 100th Birthday: A History of Horses, contaminated Polio Vaccines and Scandal | Evolution in CBER | American Red Cross: details of why they are being held in contempt of their 1993 consent decree |
| August, 2002 | 7(8) | Newest Post-Approval Hot Topic: Immungenicity Firms Scramble to Meet New Requirements | Post Approval Commitments for HADA studies. A look back at approved products for 3 years | EU Guidance about comparability tackles even more details for "generic" biologics |
| September, 2002 | 7(9) | Changes and Uncertainty at CBER; Specified Products Slated to Move to CDER | Vaccine Shortage Sparks GAO ScruntinyRegulatory Correspondence PrimerHelp for drafting a Common Technical Document dossierConsultation paper for human tissue engineering and tissue-engineered products. | |
| October 2002 | 7(10) | Global Firms Impacted by Lack of Global Harmony; Is the Best Hope for Harmonization Through Informal Procedures? | Prescription Drug User Fee Act... Good or Bad for Pharmaceuticals?System Based Inspections-ResultsUnited Kingdom Goes Public with Inspection ResultsTeam Biologics Inspection Results - Another Year.... Fewer Regulatory Actions? | |
| November 2002 | 7(11) | CBER Products Moving to CDER - Some Go and Some Stay | FDA's Long Awaited Aseptic Processing PaperViral Safety Evaluation Study: Are They Really 'Quality Added"?Guidances, Scientific Summaries and No More MRA?FDA Approvals: Learning from Other's Successes and MistakesBiopharmaceuticals from Plants | |
| December 2002 | 7(12) | Bioterrorism and BioPharm; A Match Made on 9/11 | Year-End Flurry of Documents Hit the WebInspection Results Continue Emphasis on Failure Investigations and ValidationCBER Approvals for 2002 |
2001
|
Date |
Vol. (No.) |
Feature Article(s) |
Meeting Notes |
Other Feature(s) |
| January, 2001 | 6(1) | Another Year of Shifting Regulatory Priorities : Harmonization Efforts Fall and Thrive in 2000 | Year in Review: CBER Approves Six New Therapeutic BLAs in 2000Year in Review: Warning Letters Provide Insight into Industry Problems | |
| February, 2001 | 6(2) | Drugs' New Inspectional Paradigm Rolls Out: Systems Inspections for the Drug Industry | Not all System Inspection are Created Equal | Is Reprocessing a Violation of cGMPs? Sometimes Yes…Sometimes No…Case-by-CaseHarmonization Section Debuts (Sort of…) |
| March, 2001 | 6(3) | EMEA Tackles Another Controversial Topic: Water Quality Guidance Says Thumbs Down to RO | Gene Therapy Clinical Trial Monitoring Results Mixed Letters Not so Good - Audit Results Good…Sort of | |
| April, 2001 | 6(4) | Reprocessing Continues to Draw Industry Attention: Filter Integrity Failures Cause Problems | Electronic Submissions Now a RealityNon-Gene Therapy Clinical Investigators Scrutinized | |
| May, 2001 | 6(5) | FDA and EMEA Reach Different Safety Conclusions: Identical Input Data Does Not Always Mean Harmonized Action | Fast Track Designation Stripped From ProductCounterfeit BioPharmaceuticals Hit the U.S. MarketPooling Musculoskeletal Tissues Frowned Upon by FDAValidation Annex Implemented Next Month2 New Product Approvals..but the Road Was Not Smooth | |
| June, 2001 | 6(6) | GAO Issues Reports Impacting the FDA: Pediatric Exclusivity, Flu Vaccine Shortages and Clinical Trials | IND Meeting Guidance Finalized: Emphasis Placed on End-Of-Phase 2 Meeting | Guidance for Gene Therapy Products PublishedIncreasing Pressure on Quality ManagementHints About Managing Outside Contracts |
| July, 2001 | 6(7) | The Common Technical Document: Just How Common Is It? | Electronic CTD Becomes A Step Two Document Biologics Product Deviation Reporting UpdateErrors and Accidents - The TrendsElectronic Common Technical Document SpecificationsManaging Qual. and Reg. Expectations with Contractors and Alliance Partners | |
| August, 2001 | 6(8) | Stem Cells: New Product - Old Paradigm? The Process is the Product | Research Grade Reagents During Clinical Manufacturing - FDAer Provides Some Guidance | Biological Deviation Reporting GuidanceProposed Pharma Legislation Reform Touches on Hot Topics |
| September, 2001 | 6(9) | Tracking Down Sources for Bovine-Derived Material: On the Trail of a Moving Target | Animal Derived ComponentsDrafting the Common Technical Document for the USGood Clinical Practice | |
| October, 2001 | 6(10) | FDA Issues Guidance on Part 11: Hopefully This is the First of the Promised Series | Process Validation for Biologics: High Expectations | CPMP's Clinical Inspections |
| November, 2001 | 6(11) | Viral Clearance Safety Studies - Industry Trends: Small Scale Studies, Generic Studies, Standardized Virus Pools | Technical Nitty-Gritty for Viral Clearance StudiesQuantitative PCR Methods Now Used in Viral Clearance Studies | 21 CFR Part 11 and Your Small Company |
| December, 2001 |
6(12) |
GMPs During Development Taking a Walk on the Wild Side |
GMP Problems During Development |
GMP References During DevelopmentGMPs During the Manufacture of Clinical Trial Material21 CRF Part 11 and Small Companies - Manufacturing Issues |
2000
|
Date |
Vol. (No.) |
Feature Article(s) |
Meeting Notes |
Other Feature(s) |
|
January, 2000 |
5(1) |
Assuring Lab Equipment Performance |
FDAer’s Advice on Equipment Qualification |
Lab Equipment Performance Assurance References and Resources |
|
February, 2000 |
5(2) |
Product Safety Issues: Regulation by Reaction to Tragedy? |
|
Bioresearch Monitoring Program: What is it and Where is it Going? 483s from Controversial Gene Therapy Trial |
|
March, 2000 |
5(3) |
Gene Therapy Clinical Trials Continue to Draw Fire: Is Oversight of Clinical Drug Production on the Way? |
|
More Bad News for Gene Therapy Clinical Trials Players in Clinical Trial Oversight Step 2 ICH Common Technical Document Guidance |
| April 2000 | 5(4) | Off-Label Information Controversy Continues: FDA and WLF Agree Then Disagree—New Motion Filed | Comparability Case Studies: Success Stories |
News You Can Use: Comparability Protocols—Not a Panacea but Useful Dos Don’ts and What-fors of Comparability Protocols |
| May, 2000 | 5(5) | Team Biologics Regulatory Action Scorecard | Regulatory Action Tallied by Industry Segment | BIMO Web Page UpdatedNew Members Added to Team Biologics Core GroupVaccine Warning Letters |
| June, 2000 | 5(6) | Gene Therapy Clinical Trials Continue to Draw Fire | CBER's Take on Comparability Protocols | Gazing into the Crystal Ball for Clinical TrialsComparability Protocols: Yeas and NaysInspector General's 1988 Recommendations Ignored |
| July, 2000 | 5(7) | Orphan Drug Incentives in the Global Market-Programs Around the World: Some Work, Some Don't | Part 11 Meeting: Short on Regulatory Guidance, Long on Vendor Talks | CPMP Comparability Guidance: Multisource Product….A Generic by Any Other Name |
| August, 2000 | 5(8) | EC-US Mutual Recognition Agreement Stumbles | Anatomy of US/EC MRAICH Update: Q3A(R) "Draft Revised Guidance on Impurities in New Drug Substances" and M4 "Common Technical Document"Draft Guidance for Active Pharmaceutical Ingredients: Spelling Out the Future of CGMPS? | |
| September, 2000 | 5(9) | Cleaning Validation Remains Problematic | More About Q7A: GMPs for API's | Cleaning Validation 483 Observations |
| October, 2000 | 5(10) | Vaccine Manufacturing Under Fire: Two Consent Decrees Rock Industry | Parledale Falls Off the WagonDraft Guidance for Analytical MethodsEuorpe This Month: Orphan Drug Status and More | |
| November, 2000 | 5(11) | Step Four Common Technical Document Released | Common Technical Document Format | Quality Information for CTDUSP to Adopt SST ChangesErrors and Accidents Final Rule Announced |
|
December, 2000 |
5(12) |
Anthrax Vaccine Grabs Spotlight Again: Team Biologics Inspection Critical of Major Systems |
|
Systems Inspections for DrugsAnother Rough Inspection for the Vaccine IndustryEMEA Tackles Controversial Issues: TSE and Thiomersol |
|
January, 1999 |
4(1) |
Lessons Learned about Team Biologics |
Top Team Biologics 483s |
Year in Review: Warning Letters and 483 Citations |
|
February, 1999 |
4(2) |
The Future of Generic Biotech Drugs |
Generic Terminology |
SKB Warning Letter |
|
March, 1999 |
4(3) |
Fast Track: Insights to be Gained from Recent Approvals |
Team Biologics Top 4 Problem Areas |
Stability Practices: Varying Expiration Dates can be a Red Flag New: Warning Letters at a Glance |
|
April, 1999 |
4(4) |
Computer Validation, Terminology and Inspection Results |
Computer Validation Related 483s |
Year 2000: The FDA Wants to Know What You Are Doing! FDA Y2K Resources |
|
May, 1999 |
4(5) |
Get Your Antibody Approved Fast: CBER Director Tells You How |
CBERs List of MoAb Product Development Issues Immunogenicity of MoAbs Approved for Human Use |
Part 11 CPG Issued |
|
June, 1999 |
4(6) |
Regulatory Actions on the Upswing? Are Team Inspections of Sterile Drugs on the Horizon? |
License Revocation Warning Signs Team Biologics: Enforcement Action Scorecard |
On the Web: Warning Letters from Team Biologics Inspections |
|
July, 1999 |
4(7) |
Quality in the Clinic: The Compliance Bar Rises |
Performing a GCP Audit: Best Practices Phase I Clinical Studies Auditing—A New Frontier |
Monoclonal Antibodies used as Manufacturing Reagents |
|
August, 1999 |
4(8) |
Orphan Drugs |
|
Sameness Defined for Orphan Monoclonal Antibodies Shared Manufacturing |
|
September, 1999 |
4(9) |
Failing Failure Investigations – An Industry Problem |
Six Areas of Concern for Process Validations |
Off-Label Legal Battleground…..FDA Wins Some and Loses Some |
|
October, 1999 |
4(10) |
Laboratory Issues Loom Large: FDA Investigators in the R&D Labs? |
Another Inspection Paradigm? Top Down Inspections May Come to Biopharmaceuticals |
Gifts to FDA FDAer’s Hints for Avoiding 483s FDA to Appeal Off-Label Ruling |
|
November, 1999 |
4(11) |
CBER Regulated Devices |
Jane Henney: Putting the “S” Back in Regualtions |
Team Biologics Inspection CPGM for Therapeutic Products |
|
December, 1999 |
4(12) |
FDA Looking More Aggressive on Consent Decrees: Abbott Injunction |
|
1999 In Review Electronic BLA Guidances |
|
Date |
Vol. (No.) |
Feature Article(s) |
Meeting Notes |
Other Feature(s) |
|
January, 1998 |
3(1) |
CMC for Phase II/III INDs |
|
Year in Review: Validation Leads the Pack for 1997 |
|
February, 1998 |
3(2) |
Comparability Protocol Implementation Nears |
Changes Not Suitable for Comparability Protocols Manufacturing Changes 1994 vs. 1996 Inspection Preparation and Survival |
On the FDA Home Page: Interesting Tidbits |
|
March, 1998 |
3(3) |
The Pre-Approval Inspection Process |
Is the Door Opening for a New Type of Fast Track Approval? |
On the FDA Home Page: FDA is Coming to Grips with The Modernization Act |
|
April, 1998 |
3(4) |
CGMP Workshop for Analytical Labs |
|
European GMPs Available on the Internet ICH Draft Biotech Specifications Document |
|
May, 1998 |
3(5) |
Team Biologics Shakes Up Fractionators |
One Company’s Experience with Team Biologics |
Team Biologics Inspectors: Who Are They? |
|
June, 1998 |
3(6) |
PDUFA 2 Goals—Changes in Business as Usual |
|
FDA Documents: New Stability Guidance—100+ Pages of Wisdom FDA Web Site Notes: Guidances—A Baker’s Dozen Issued Last Month |
|
July, 1998 |
3(7) |
EU-US Mutual Recognition of Inspections—Will it Work? |
CDER First Party Audits |
Is Your Product Included in the EU-US MRA? |
|
August/ September, 1998 |
3(8/9) |
FDA Guidances Unconstitutional: Distribution of Off-label Information Remains Controversial |
|
A Primer on Off-Label Use Revisions to the General Safety Test Requirements for Biological Products |
|
October, 1998 |
3(10) |
Medical Device Pilot Extends to Pharmaceuticals: Pre-announced Inspections for Next Year? |
Clinic to Licensure in in Three and a Half Years: One Company’s Experience |
Out of Specification Test Results Guidance: Laboratory Failure Investigation Hints |
|
November, 1998 |
3(11) |
Out of Specification Results 5 Years after Barr: Confusion and Clarifications, but Few Conclusions |
Do’s and Don’ts for Handling Out of Specification Results |
EU-US Mutual Recognition Final Rule Highlights |
|
January, 1997 |
2(1) |
1996 in Review Road Map for Specified Biotech Product Regulations |
|
ICH in 96 1996 Product Specific Trends |
|
February, 1997 |
2(2) |
Process Changes Without Clinical Trials |
|
Fax on Demand: CMC Guidance for Autologous Somatic Cell Therapy Warning Letters: Inspection Shuts Down European Firm |
|
March, 1997 |
2(3) |
CGMP Workshop for Analytical Labs |
Sample 483 Citations Address Computer Software Issues |
Fax on Demand: New Monoclonal Antibody Points to Consider Enforcement Trends: Warning Letter Focuses on Software and Stability Studies |
|
April, 1997 |
2(4) |
ICH Process Nearing Completion? |
|
Fax on Demand: Guidance for Industry: Providing Evidence of Effectiveness for Human Drug and Biological Products Enforcement Trends: Warning Letter Focuses on Monitoring and Documentation |
|
May, 1997 |
2(5) |
Accelerating Drug Development And Approval |
Challenges of Accelerated Approval Analytical Programs Key for Expedited Approval |
Fax on Demand: Draft ICH Document about Cell Substrates |
|
June, 1997 |
2(6) |
The Approachable FDA Exists but Compliance is Still the Bottom Line/NICE Audits |
Tips on Working with FDA from an FDA Insider Soon to Appear: Comparability Protocols |
In the Federal Register: ICH Guideline on Analytical Method Validation Enforcement Trends: Warning Letter Focuses on Specifications, Validation, and QC Lab Issues |
|
July, 1997 |
2(7) |
Manufacturing Clinical Supplies Workshop |
Chromatographic System Suitability Public Workshop |
In the News: US and EU Sign Mutual Recognition Agreements |
|
September, 1997 |
2(8/9) |
Team Biologics—Biotech Inspections by ORA |
Tips for Quality and Regulatory from Bio-97 |
Fax on Demand: Guidances Delineate Types of Changes Allowed |
|
October, 1997 |
2(10) |
Industrial Experience with Team Inspections |
Conflicting Opinions Surface at Comparability Protocol Workshop |
In the News: Final Rule Manufacturing Changes |
|
November, 1997 |
2(11/12) |
Electronic FOI |
Implementation of EU/US Mutual Recognition Agreements Raises Doubts |
|
|
Date |
Vol. (No.) |
Feature Article(s) |
Meeting Notes |
Other Feature(s) |
|
June, 1996 |
1(6) |
Biotech Specifications Symposium |
Validate or Specify? |
In the Literature: Validation Remains Key in 96; Enforcement Trends: Documentation Tops the Charts |
|
July, 1996 |
1(7) |
QC Labs Likely Candidates for Stricter Inspections |
Common Inspection Issues |
Enforcement Trends: Compliance at Clinical Sites In the Federal Register: CBER Issues Final Rule for ELA Elimination; Proposed Amendment of CGMPs |
|
August, 1996 |
1(8) |
Cleaning Topics at BioPharm 96 Internet Information Resources |
|
In the Literature: Swabbing and TOC Enforcement Trends: The Paper Trail Leads the Pack for 483s In the Federal Register: Final Biotech Stability Guideline; Biological Product Regulations Revoked |
|
September, 1996 |
1(9) |
Hints from the Office of Compliance |
|
In the Literature: Assay Validation Fax on Demand: New CMC Guidance Issued Data Security for Microsoft Excel |
|
October, 1996 |
1(10) |
PDA/FDA Conference |
Clinical Supplies Facilities Inspections |
Active Pharmaceutical Ingredients Draft |
|
November/December, 1996 |
1(11) |
Errors and Accident Reports |
Implications of CBER’s Suggested Regulatory Changes Pre-Approval Inspections |
Fax on Demand: Draft PTC for Plasmid DNA Vaccines |
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Office: 916-729-0109 |
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