Pharmaceutical Technology - March 2021

Pharmaceutical Technology - Regulatory Sourcebook - March 2021

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Page 53 of 61

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Ap- proved ANDAs (PDA) • Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products, Draft Guidance (PDF) • Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 (PDF) • Best Practices in Developing Proprietary Names for Human Prescription Drug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Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed Guidance for Industry, Draft Guidance (PDF) • Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry (PDF) • Chemistry, Manufacturing, and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Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information Guidance for Industry, Draft Guidance (PDF) • Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c) (PDF) • Competitive Generic Therapies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Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry, Draft Guidance (PDF) • Data Integrity and Compliance With Current Good Manufacturing Practice Guidance for Industry (PDF) • Demonstrating Substantial Evidence of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)

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