Pharmaceutical Technology - December 2019

Pharmaceutical Technology - Regulatory Sourcebook

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Page 40 of 43

Pharmaceutical Technology REGULATORY SOURCEBOOK DECEMBER 2019 41 Resources: Guidelines T he regulatory nature of the bio/pharma- ceutical industry requires close adher- ence to regulations, good manufacturing practices, and guidelines. The websites of regulatory authorities provide information to assist drug development and manufacturing organiza- tions in navigating the regulatory process. This sec- tion lists information sources to key topics; click the appropriate link to access the online information. The following pages list key guidance documents from FDA, European Medicines Agency (EMA), the World Health Organization (WHO), and the Inter- national Council for Harmonisation (ICH)*. US Food and Drug Administration Resources FDA Human Drugs FDA Animal and 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 Select FDA Guidance Documents • Advancement of Emerging Technology Appli- cations for Pharmaceutical Innovation and Modernization Guidance for Industry (PDF) • Analytical Procedures and Methods Validation for Drugs and Biologics (PDF) • Assay Development and Validation for Immu- nogenicity Testing of Therapeutic Protein Products, Draft Guidance (PDF) • CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports (PDF) • Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information Guidance for Industry, Draft Guidance (PDF) • Contract Manufacturing Arrangements for Drugs: Quality Agreements (PDF) • Current Good Manufacturing Practice for Phase 1 Investigational Drugs (PDF) •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) Resources, Guidelines, and Guidance Documents tashatuvango -

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