Pharmaceutical Technology - March 2021

Pharmaceutical Technology - Regulatory Sourcebook - March 2021

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52 Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2021 P h a r mTe c h . c o m Resources: Guidelines T he regulatory nature of the bio/pharma- ceutical industry requires close adher- ence to regulations, good manufactuing practices, and guidelines. The websites of regulatory authorities provide information to as- sist 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 International 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 COVID-19 Related Guidance Documents • COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers, Guidance for Industry (PDF) • COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products (PDF) • COVID-19: Developing Drugs and Biological Products for Treatment or Prevention (PDF) • Development and Licensure of Vaccines to Prevent COVID-19 (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) • Emergency Use Authorization for Vaccines to Prevent COVID-19 (PDF) • Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Resources, Guidelines, and Guidance Documents tashatuvango - Access key regulatory and standard setting resources, guidance documents, and guidelines by clicking on the title of the document.

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