54 Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2021 P h a r mTe c h . c o m
Resources: Guidelines
Biological Products Manufacturing (PDF)
• Investigational COVID-19 Convalescent
Plasma, Guidance for Industry (PDF)
• Manufacturing, Supply Chain, and Drug and
Biological Product Inspections During
COVID-19 Public Health Emergency
Questions and Answers (PDF)
• Review Timelines for Applicant Responses to
Complete Response Letters When a Facility
Assessment Is Needed During the COVID-19
Public Health Emergency (PDF)
• Resuming Normal Drug and Biologics
Manufacturing Operations During the
COVID-19 Public Health Emergency (PDF)
Select FDA Guidance Documents
• Analytical Procedures and Methods Validation
for Drugs and Biologics (PDF)
• ANDA Submissions–Amendments and Re-
quests for Final Approval to Tentatively Ap-
proved ANDAs (PDA)
• Assay Development and Validation for
Immunogenicity Testing of Therapeutic
Protein Products, Draft Guidance (PDF)
• Assessing User Fees Under the Biosimilar User
Fee Amendments of 2017 (PDF)
• Best Practices in Developing Proprietary Names
for Human Prescription Drug Products
• Biosimilars and Interchangeable Biosimilars:
Licensure for Fewer Than All Conditions of
Use for Which the Reference Product Has
Been Licensed Guidance for Industry, Draft
Guidance (PDF)
• Cannabis and Cannabis-Derived Compounds:
Quality Considerations for Clinical Research
Guidance for Industry (PDF)
• Chemistry, Manufacturing, and Control
(CMC) Information for Human Gene
Therapy Investigational New Drug
Applications (INDs) (PDF)
• Comparability Protocols for Human Drugs
and Biologics: Chemistry, Manufacturing,
and Controls Information Guidance for
Industry, Draft Guidance (PDF)
• Compliance Policy for the Quantity of
Bioavailability and Bioequivalence Samples
Retained Under 21 CFR 320.38(c) (PDF)
• Competitive Generic Therapies (PDF)
• Contract Manufacturing Arrangements for
Drugs: Quality Agreements (PDF)
• Control of Nitrosamine Impurities in Human
Drugs (PDF)
• Current Good Manufacturing Practice—
Guidance for Human Drug Compounding
Outsourcing Facilities Under Section 503B of
the FD&C Act Guidance for Industry, Draft
Guidance (PDF)
• Data Integrity and Compliance With Current
Good Manufacturing Practice Guidance for
Industry (PDF)
• Demonstrating Substantial Evidence of
Effectiveness for Human Drug and Biological
Products, Draft Guidance (PDF)
• Elemental Impurities in Drug Products
Guidance for Industry (PDF)
• Failure to Respond to an ANDA Complete
Response Letter Within the Regulatory
Timeframe Guidance for Industry (PDF)
• Harmonizing Compendial Standards With
Drug Application Approval Using the USP
Pending Monograph Process, Guidance for
Industry, Draft Guidance (PDF)
• Human Gene Therapy for Neurodegenerative
Diseases, Draft Guidance (PDF)
