Pharmaceutical Technology - March 2020

Pharmaceutical Technology - Regulatory Sourcebook

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48 Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2020 P h a r mTe c h . c o m Resources: Guidelines T he regulatory nature of the bio/pharmaceu- tical industry requires close adherence to regulations, good manufactuing practices, and guidelines. The websites of regulatory authorities provide information to assist drug develop- ment and manufacturing organizations in navigating the regulatory process. This section lists information sources to key topics; click the appropriate link to ac- cess the online information. The following pages list key guidance documents from FDA, European Medicines Agency (EMA), the World Health Organization (WHO), and the Interna- tional 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 • Analytical Procedures and Methods Validation for Drugs and Biologics (PDF) • Assay Development and Validation for Immu- nogenicity Testing of Therapeutic Protein Prod- ucts, Draft Guidance (PDF) • Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 Guidance for Industry (PDF) • Biosimilars and Interchangeable Biosimilars: Li- censure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Li- censed Guidance for Industry, Draft Guidance (PDF) • Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investi- gational New Drug Applications (INDs) (PDF) • Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Con- trols Information Guidance for Industry, Draft Guidance (PDF) • Contract Manufacturing Arrangements for Drugs: Quality Agreements (PDF) Resources, Guidelines, and Guidance Documents tashatuvango - Stock.adobe.com

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