BioPharm International - March2020

BioPharm International - Regulatory

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Page 50 of 51 March 2020 BioPharm International eBook 51 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 guide- lines. The websites of regulatory authori- ties provide information to assist drug development and manufacturing orga- nizations in navigating the regulatory process. This section lists information sources to key topics; click the appropri- ate link to access the online information. The following pages list key guid- ance documents f rom the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Wor ld Health O rganiz ation (WHO), 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 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and Biologics (PDF) • Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products, Draft Guidance (PDF) • Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 Guidance for Industry (PDF) • Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed Guidance for Industry, Draft Guidance (PDF) • Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) (PDF) • Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information Guidance for Industry, Draft Guidance (PDF) • Contract Manufacturing Arrangements for Drugs: Quality Agreements (PDF) • Current Good Manufacturing Practice for Phase 1 Investigational Drugs (PDF) •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 Monograph Process Guidance for Industry, Draft Guidance • Human Gene Therapy for Rare Diseases (PDF) • Importation of Certain FDA- Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act, Draft Guidance (PDF) • INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information (PDF) • Long Term Follow-up After Administration of Human Gene Therapy Products • PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (PDF) • Postapproval Changes to Drug Substances Guidance for Industry, Draft Guidance (PDF)

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