Notes

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Topic Article Title (and Keywords)

Reference (and page[s])

483s See Inspection Results and Analysis
Adverse Event Reporting and BPDRs FDA Announces Latest Changes to the eBPDR Reporting System BioQuality 16(11), Nov, 2011 (p15)
Animal Rule CBER Presents Their View of Bridging Animal to Human Data BioQuality 15(12), Dec, 2010 (p3)
Pathway to Licensure for Protective antigen-based Anthrax Vaccines for a Post-exposure Prophylaxis Indication Using the Animal rule BioQuality 15(12), Dec, 2010 (p3)
Approvals FDA Approval of GINTUIT BioQuality 16(11), Nov, 2011 (p19)
BLA Supplement and Biological Device Approvals BioQuality 16(11), Nov, 2011 (p15)
FDA approves first cord blood product BioQuality 16(11), Nov, 2011 (p16)
FDA approves Erbitux to treat late-stage head and neck cancer BioQuality 16(11), Nov, 2011 (p16)
2010 Product Approvals BioQuality 16(1), Jan, 2011 (p3)
European Approval Process BioQuality 15(6), Jun, 2010 (p3)
First Cancer Vaccine Achieves Marketing Status: FDA Licenses Dendreon’s Provenge BioQuality 15(4), Apr, 2010 (p4)
2009 CDER Biopharma/Biologics Approvals BioQuality 15(1), Jan, 2010 (p3)
 Avastin 2011–The Year in Review (accelerated approval; revocation/withdrawal of approval) BioQuality 17(1), Jan, 2012 (p1)
Avastin Out: FDA puts the brakes on accelerated approval BioQuality 16(11), Nov, 2011 (p1)
FDA Plans to Remove Avastin®’s Breast Cancer Indication: Meanwhile EMA grants authorization for Avastin + Paclitaxel BioQuality 16(6), June, 2011 (p1)
Bioanalytical Methods EMA Draft Bioanalytical Method Validation Guidance Document BioQuality 15(7/8), Aug, 2010 (p2)
Biological Potency–see Potency, Biological
Biosimilars, biobetters, etc. BioBetters Face Off Against BioSimilars:But How Much Better is Better Enough? (biosimilar risk/rewards; probabilities of success) BioQuality 17(3), Mar, 2012 (p1)
BioSimilars -all Grown-up with Grown-Up Problems (interchangeability; global references for approval; clinical relevance of heterogeneity; INN–WHO EWG Recommendations) Biosimilar Special Edition 2012
BioSimilar by any other Name……Does it Smell As Sweet? INN Naming Conventions Cause Uproar (reprint of 2006 Article) (controversies surrounding INN) Biosimilar Special Edition 2012
Development Re-emphasizes Importance of HCP Analysis Biosimilar Special Edition 2012
FDA Releases Three New Guidance Documents for Biosimilars (summary of the guidances) Biosimilar Special Edition 2012
Definitions of Terms Relating to Biosimilars Biosimilar Special Edition 2012
European Medicines Agency (EMA) Biosimilar Guidelines (list of documents) Biosimilar Special Edition 2012
BioQuality Publishes Special Issue on Biosimilars BioQuality 17(2), Feb, 2012 (p1)
2011–The Year in Review (comparability; conflicting opinions) BioQuality 17(1), Feb, 2012 (p1)
European News (guidance document) BioQuality 17(1), Jan, 2012 (p6)
Biosimilars Remain a Dominant Topic: Notable and Quotable from AAPS NBC 2011 BioQuality 16(7), Jul, 2011 (p1)
Biosimilars and Unwanted Immunogenicity BioQuality 15(5), May, 2010 (p2)
US Finally Gets Approval Pathway for Generic Biologics BioQuality 15(5), May, 2010 (p4)
Biosimilar Approval Exceptions BioQuality 15(5), May, 2010 (p9)
Health Canada Releases Final Guidance on Generic (Subsequent Entry) Biologics BioQuality 15(3), Mar, 2010 (p4)
Cellular Therapies Manufacturing When the Batch Size Equals One: New Manufacturing Paradigms Discussed at Conference BioQuality 17(6), Apr, 2012 (p3)
FDA Approval of GINTUIT BioQuality 17(3), Mar, 2012 (p19)
FDA approves first cord blood product BioQuality 16(11), Nov, 2011 (p16)
Change Control and Implementation EU, US and Canada — A Plethora of Change Procedures (commercial product change implementation, comparison of procedures) BioQuality 16(2), Feb, 2011 (p3)
A List of CMC Changes You Can Implement in An Annual Report BioQuality 16(2), Feb, 2011 (p4)
Comparability 2011–The Year in Review (comparison of US/EU/Canada procedures [p4]; qualitative v. quantitative) BioQuality 17(1), Jan, 2012 (p1)
Making Changes—The Shifting Sands of Comparability BioQuality 16(2), Feb, 2011 (p1)
Manufacturing Changes Guidance (Canada, EU, US) BioQuality 16(2), Feb, 2011 (p2)
Pharmacokinetic (PK) Studies for Comparability BioQuality 15(7/8), Aug, 2010 (p2)
Comparability Studies—Still a Scientific Art;Guidances are Helpful, but not the Whole Story BioQuality 15(3), Mar, 2010 (p1)
Counterfeiting and Intentional Adulteration Preventing Entry of Counterfeit APIs (EU) BioQuality 16(12), Dec, 2011 (p4)
GAO Report Faults FDA for Not Doing More to Address Economically-Motivated Adulteration BioQuality 16(11), Nov, 2011 (p10)
Electronic Records   21CFR Part 11 Question about Archiving of Chromatograms Answered BioQuality 16(12), Dec, 2011 (p5)
New EU Annex 11 BioQuality 16(6), June, 2011 (p3)
FDA, EMA, et al. Priorities and Future Directions FDA Goes Global BioQuality 17(5), May, 2012 (p4)
FDA/CDER has released a Guidance Agenda of New and Revised Draft Guidances BioQuality 17(3), Mar, 2012 (p3)
2011–The Year in Review (strategic priorities) BioQuality 17(1), Jan, 2012 (p1)
FDA-TRACK (Transparency, Results, Accountability, Credibility, Knowledge Sharing) BioQuality 16(12), Dec, 2011 (p3)
Brazilian Regulatory Agency Establishes Biological Medicines Office BioQuality 16(10), Oct, 2011 (p5)
FDA Publishes Proposals for Compliance/Enforcement Data Transparency BioQuality 16(10), Oct, 2011 (p17)
Which Way, FDA? Agency Outlines Strategic Priorities for Next 5 Years BioQuality 16(5), May, 2011 (p1)
FDA’s Key Strategies for Human Drugs and Biologics BioQuality 16(5), May, 2011 (p4)
Update on FDA’s Quality Initiatives: QbD Continues to be agency focus BioQuality 16(3), Mar, 2011 (p1)
2010—Year in Review(FDA Finally Gets Into PIC/S, EMA Celebrates an Anniversary and PublishesAnother Roadmap, FDA Announces Enforcement Priorities) BioQuality 16(1), Jan, 2011 (p1)
Which Way FDA? A summary of trends at the agency BioQuality 15(9), Sep, 2010 (p1)
FDA Office of Enforcement Director Reveals Agency’s Enforcement Strategy BioQuality 15(9), Sep, 2010 (p1)
Q & A with the Regulators: Part 3 of a 3 Part Series BioQuality 15(7/8), Aug, 2010 (p1)
Q and A with the Regulators: Part 2 of a 3-part Series BioQuality 15(6), Jun, 2010 (p1)
Q and A with the Regulators: Part 1 of a 3-Part Series (Everything You’ve Wanted to Know but Were Too Afraid to Ask) BioQuality 15(5), May, 2010 (p1)
Which Way, FDA? (safety, globalization, harmonization, regulatory consistency BioQuality 15(2), Feb, 2010 (p1)
EU Roadmap to 2015 BioQuality 15(2), Feb, 2010 (p3)
First-in-human Studies Q & A with the Regulators: Part 3 of a 3 Part Series BioQuality 15(7/8), Aug, 2010 (p1)
Good Distribution Practices (GDP) European News (IPEC guideline) BioQuality 17(1), Jan, 2012 (p6)
Drug Transport and Storage Guide Published by the Irish Medicines Board (IMB) BioQuality 16(10), Oct, 2011 (p18)
Draft Guideline on Good Distribution Practice of Medicinal Products for Human Use. BioQuality 16(7), Jul, 2011 (p4)
Immunogenecity–see Unwanted Immunogenicity
Inspection Results and Analysis Inspection and Enforcement News (WL’s to foreign firms) BioQuality 17(5), May, 2012 (p8)
A Checklist of Questions for Assessing a 483 Observation’s Significance BioQuality 17(1), Jan, 2012 (p5)BioQuality 16(10), Oct, 2011 (p6)
A British View on the Top 10 GMP Deficiencies BioQuality 16(12), Dec, 2011 (p16)
Novartis Warning Letter BioQuality 16(12), Dec, 2011 (p16)
FDA Compliance Director Details CGMP Hot Spots: How FDA Evaluates the Significance of 483 Notices of Deficiency BioQuality 16(10), Oct, 2011 (p1)
FDA Releases FY2010 Inspection Summary and Observations BioQuality 16(10), Oct, 2011 (p17)
FDA Publishes Proposals for Compliance/Enforcement Data Transparency BioQuality 16(10), Oct, 2011 (p17)
Every Sponsor’s Worst Nightmare: 5 Years of Data from Cetero’s Bioanalytical Lab Questioned by FDA BioQuality 16(9), Sep, 2011 (p1)
Analysis of CSL Inspections BioQuality 16(9), Sep, 2011 (p10)
Australian Flu Vaccine Manufacturer CSL,Ltd. Receives FDA Warning Letter BioQuality 16(7), Jul, 2011 (p3)
FDA searchable inspection database BioQuality 16(7), Jul, 2011 (p4)
Reading Between the Lines of FDA Letters BioQuality 16(5), May, 2011 (p2)
Contract Testing Firm Receives FDA Warning Letter BioQuality 15(10), Oct, 2010 (p4)
One Company’s Experience with Joint EMA/FDA Inspection BioQuality 15(9), Sep, 2010 (p3)
The Cost of Non-Compliance: CGMP Problems at Genzyme–The Price Tag Starts at $175 Million US Dollars BioQuality 15(4), Apr, 2010 (p1)
A Decade of FDA Form 483 Notices of Deficiency BioQuality 15(1), Jan, 2010 (p5)
Typical 483s exemplify Universal Problems BioQuality 15(1), Jan, 2010 (p6)
Inspectional Cooperation and Mutual Recognition PIC/S Aide-Memoire (PI-038-1): Assessment of Quality Risk Management Implementation BioQuality 17(3), Mar, 2012 (p18)
EMA has announced the continuation and expansion of international collaboration on good manufacturing practice inspections BioQuality 17(3), Mar, 2012 (p18)
All Together Now: EMA and FDA Give Mutual Recognition of Inspections another Try BioQuality 16(12), Dec, 2011 (p1)
FDA/EMA Joint Inspection Pilot Program BioQuality 15(9), Sep, 2010 (p3)
One Company’s Experience with Joint EMA/FDA Inspection BioQuality 15(9), Sep, 2010 (p)
Job Descriptions Position Descriptions: Be careful what you say BioQuality 15(9), Sep, 2010 (p3)
Media Fills and process simulations FDA has released a Media Fill Guidance Document (PET drugs, BioQuality 17(4), Apr, 2012 (p2)
Particulates Q and A with the Regulators: Part 2 of a 3-part Series BioQuality 15(6), Jun, 2010 (p1)
Personalized and Molecular Medicine FDA Approves New Test for Herceptin Treatment Candidacy BioQuality 16(6), June, 2011 (p9)
Pharmacogenomics The European Medicines Agency guideline on the use of pharmacogenetics in evaluating the pharmacokinetics of medicines BioQuality 17(2), Feb, 2012 (p12)
Pharmacovigilance EMA has published an updated set of mandatory requirements for marketing authorization holders to comply with Article 57(2) BioQuality 17(3), Mar, 2012 (p18)
Potency, biological Potency Remains a Critical Quality AttributeNo Direct FDA Guidance Planned for Validation (potency and product MOA; “thaw and go” cells; potency and product stability) BioQuality 17(5), May, 2012 (p1)
Taking Out the Beast in Vaccines?Fewer Animals in Routine Release, but More in Development BioQuality 15(12), Dec, 2010 (p1)
Recent Conferences Put Bioassays in the Spotlight: Assessing similarity causes controversy BioQuality 15(10), Oct, 2010 (p1)
Product Development European Drug Development Problems and Reasons BioQuality 16(12), Dec, 2011 (p5)
US Faces Possible Drug Development and Approval Crisis BioQuality 16(12), Dec, 2011 (p16)
CASSS WCBP Discusses Product Development Approaches and Pitfalls Communication, Strategic Use of Resources, and Listening to Your Regulators BioQuality 16(3), Mar, 2011 (p4)
Quality by Design (QbD) 2011–The Year in Review (QbD quick refresher) BioQuality 17(1), Jan, 2012 (p4)
QbD Guide Published by ISPE BioQuality 16(11), Nov, 2011 (p17)
Update on FDA’s Quality Initiatives: QbD Continues to be agency focus BioQuality 16(3), Mar, 2011 (p1)
Regulatory Agency Fees Fees payable to the European Medicines Agency BioQuality 17(3), Mar, 2012 (p19)
Regulatory Science Basic v. Regulatory Science BioQuality 15(5), May, 2010 (p2)
Safety GAO Proposes Biological Lab Safety Reporting System BioQuality 15(10), Oct, 2010 (p3)
Viral Safety BioQuality 15(5), May, 2010 (p1)
Components of Extraneous Virus PCV1 in GSK’s Rotavirus Vaccine Rotarix BioQuality 15(3), Mar, 2010 (p5)
Somatotropins EU Safety Review BioQuality 16(12), Dec, 2011 (p4)
Sterility Testing FDA Amends Sterility Test Requirements:Door Officially open For Rapid Microbiological Tests BioQuality 17(5), May, 2012 (p3)
Submissions and Applications eSubmission Gateway to be launchedby EMA BioQuality 16(11), Nov, 2011 (p18)
Sub-visible Particles–see Particulates
Unwanted Immunogenicity Biosimilars and Unwanted Immunogenicity BioQuality 15(5), May, 2010 (p2)
FDA Issues Unwanted Immunogenicity Guidance BioQuality 15(3), Mar, 2010 (p3)
Vaccines   FDA Releases Vaccine Guidance for Immediate Implementation BioQuality 16(12), Dec, 2011 (p18)
Questions and Answers Changed in the New Vaccine Guidance BioQuality 16(12), Dec, 2011 (p17)
Validation Lifecycle Method Validation Report Coming Soon: PDA Report to Cover Method Transfer and Replacement BioQuality 17(4), Apr, 2012 (p1)
FDAer Talk on Process Validation BioQuality 16(11), Nov, 2011 (p17)
Industry Comments on Process Validation Guidance (EU) BioQuality 16(11), Nov, 2011 (p18)
EMA Draft Bioanalytical MethodValidation Guidance Document BioQuality 15(7/8), Aug, 2010 (p2)
Warning Letters See Inspectional Results and Analysis
Year in Review 2011–The Year in Review (QBD; Comparability; FDA Priorities; Avastin; Biosimilars) BioQuality 17(1), Jan, 2012 (p1)
2010—Year in Review(FDA Finally Gets Into PIC/S, EMA Celebrates an Anniversary and Publishes Another Roadmap, FDA Announces Enforcement Priorities) BioQuality 16(1), Jan, 2011 (p1)
2009—Bad Economy=Jobs Lost + Record Fund Raising; More Jobs Lost and More Funds Raised than Previous Years BioQuality 15(1), Jan, 2010 (p1)