BioPharm International - March 2021

BioPharm International - Regulatory Sourcebook - March 2021

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Page_Header_ Page_Header_ 42 BioPharm International eBook March 2021 Regulatory Sourcebook Resources tashatuvango - Access key regulatory and standard setting resources, guidance documents, and guidelines by clicking on the title of the document. Resources, Guidelines, and Guidance Documents T he regulatory nature of the bio/ pharmaceutical industry requires close adherence to regulations, good manufacturing practices, and guidelines. The websites of regulatory authorities provide information to assist drug development and manufacturing organizations in navigating the regula- tory process. This section lists infor- mation sources to key topics; click the appropriate link to access the online information.The following pages list key guidance documents from the US Food and Drug Administration (FDA), the European Medicines Agenc y (EMA), and the International Council for Harmonisation (ICH)*. FDA RESOURCES • FDA Human Drugs • FDA Animal/Veterinary Drugs • FDA Vaccines, Blood, and Biologics • FDA Cellular & Gene Therapy Products • FDA Compliance Actions and Activities • FDA Development & Approval Process • FDA Drug Shortages • FDA Guidance Documents • FDA New Drug Approvals • FDA Regulatory Science • FDA Rules and Regulations • FDA Warning Letters US REGULATIONS • Code of Federal Regulations, Title 21, Food and Drugs • Federal Register Notices Pertaining to Drugs COVID-19 RELATED GUIDANCE DOCUMENTS • COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers, Guidance for Industry (PDF) • COVID-19: Developing Drugs and Biological Products for Treatment or Prevention (PDF) • COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID- 19 Related Drugs and Biological Products (PDF) • Development of Monoclonal Antibody Products Targeting SARS-CoV-2, Including Addressing the Impact of Emerging Variants, During the COVID 19 Public Health Emergency (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) • Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing (PDF) • Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency (PDF) FDA GUIDANCE DOCUMENTS • Analytical Procedures and Methods Validation for Drugs and Biologics (PDF) • 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 Industry (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) • 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) • Contract Manufacturing Arrangements for Drugs: Quality Agreements (PDF) • CGMP for Phase 1 Investigational Drugs (PDF)

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