Pharmaceutical Technology - September 2019

Pharmaceutical Technology - Regulatory Sourcebook

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Page 52 of 54

Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2019 53 • Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act • ANDA Submissions–Content and Format of Abbreviated New Drug Applications • Elemental Impurities in Drug Products • Labeling for Biosimilar Products FDA Draft Guidances • Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations • Nonproprietary Naming of Biological Products: Update • Quality Considerations for Continuous Manufacturing • Competitive Generic Therapies • REMS Assessment: Planning and Reporting • Biomarker Qualification: Evidentiary Framework • New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2) • Product Identifiers under the Drug Supply Chain Security Act–Questions and Answers • Postapproval Changes to Drug Substances Pending Guidances A list of the guidance documents FDA has planned for publication can be found at media/124386/download. EUROPE The following are some notable guidelines and resources from the European Medicines Agency (EMA)*: EMA Website • Pharmacovigilance Information • Guideline Search • Biosimilar Market Authorization • Research and Development Information • Marketing Authorization Information • Post-Authorization Information EMA Key and New Guidelines • Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use • Guideline on Quality, Non-Clinical and Clinical Aspects of Medicinal Products Containing Genetically Modified Cells • Guideline on Similar Biological Medicinal Products Containing Recombinant Granulocyte- Colony Stimulating Factor (Rg-CSF) • Questions and Answers on Bovine Spongiform Encephalopathies (BSE) and Vaccines • Guideline on Quality Aspects Included in the Product Information for Vaccines for Human Use • Reflection Paper on the Qualification of Non- Genotoxic Impurities • Guideline on the Quality of Water for Pharmaceutical Use • Concept Paper on the Revision of the Guideline on the Evaluation of Anticancer Medicinal Products in Man • Guideline on the Reporting of Physiologically Based Pharmacokinetic (PBPK) Modelling and Simulation • Guideline on Active Substance Master File Procedure Final • Guideline on Good Pharmacovigilance Practices (GVP) Product- or Population- Specific Considerations IV: Paediatric Population • Ref lection Paper on the Use of Extrapolation in the Development of Medicines for Paediatrics

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