BioPharm International - October 2020

BioPharm- October - Regulatory Sourcebook

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Page_Header_ Page_Header_ 54 BioPharm International eBook October 2020 www.biopharminternational.com Regulatory Sourcebook Resources tashatuvango - Stock.adobe.com 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 • R e s u m i n g N o r m a l D r u g a n d B i o l o g i c s M a n u f a c t u r i n g Operations During the COVID-19 Public Health Emergency (PDF) • Ma nu fac t u r ing, Supply Cha in, and Drug and Biological Product I n s p e c t ion s D u r i n g C OV I D - 19 P u bl ic He a lt h E m e r g e n c y Questions and Answers (PDF) • G o o d M a nu fac t u r i ng Pr ac t ice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing (PDF) • C O V I D -1 9 P u b l i c H e a l t h Emergency: General Considerations for Pre-IND Meeting Requests for COV ID-19 Related Dr ugs and Biological Products (PDF) • COVID-19: Developing Drugs and Biological Products for Treatment or Prevention (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) • Current Good Manufacturing Practice for Phase 1 Investigational Drugs (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) • Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending

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