70 Pharmaceutical Technology REGULATORY SOURCEBOOK OCTOBER 2020 P h a r mTe c h . c o m
Resources: Guidelines
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Protein Products, Draft Guidance (PDF)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 Guidance for Indus-
try (PDF)
• 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Been Licensed Guidance for Industry, Draft
Guidance (PDF)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Draft Guidance (PDF)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the FD&C Act Guidance for Industry, Draft
Guidance (PDF)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Products, Draft Guidance (PDF)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Industry, Draft Guidance (PDF)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 Rare Diseases
(PDF)
• INDs for Phase 2 and Phase 3 Studies
Chemistry, Manufacturing, and Controls
Information (PDF)
• Interpreting Sameness of Gene Therapy
Products Under the Orphan Drug
Regulations, Draft Guidance (PDF)
• Long Term Follow-up After Administration
of Human Gene Therapy Products (PDF)
• M7 Assessment and Control of DNA Reactive
(Mutagenic) Impurities in Pharmaceuticals
To Limit Potential Carcinogenic Risk—
Questions and Answers (PDF)
• NDAs: Impurities in Drug Substances (PDF)
• Notifying FDA of a Permanent
Discontinuance or Interruption in
