BioPharm International - September 2019

BioPharm - Regulatory Sourcebook

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Page_Header_ Page_Header_ 44 BioPharm International eBook September 2019 Regulatory Sourcebook tashatuvango - The following are some of the notable regulatory and standard setting resources, guidance documents, and guidelines. Resources, Guidelines, and Guidance Documents UNITED STATES The following are some key websites addressing regulatory requirements for biologics and other drug products*. • Vaccines, Blood, and Biologics • G u i d a n c e , C o m p l i a n c e , & Regulatory Information • FDA Guidance Documents • FDA Regulatory Science • F DA Compl ia nce Ac t ions a nd Activities • FDA Warning Letters Additional Resources • Federal Register • Federal Code of Regulations FDA Guidance Documents FDA's website provies a variety of regulatory resources including its list of current guidance documents. The following are some relevant guidance documents published in 2018 and 2019. Final Guidances • Postmarketing Safet y Reporting f o r C o m b i n a t i o n P r o d u c t s : Guidance for Industr y and FDA Staff • Population Pharmacokinetics • Considerations in Demonstrating I n t e r c h a n g e a b i l i t y W i t h a Reference Product • O n c o l o g y P h a r m a c e u t i c a l s : Reproductive Toxicity Testing and Labeling Recommendations • R E M S: F DA's A ppl ic at ion of Statutory Factors in Determining When a REMS Is Necessary • Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling Good Review Practice • Providing Regulatory Submissions i n E le c t ron ic For m at– C er t a i n Human Pharmaceutical Product A p p l i c a t i o n s a n d R e l a t e d Subm is sions Usi ng t he e C T D Specifications • I m m u n o g e n i c i t y Te s t i n g o f Therapeutic Protein Products— Developing and Validating Assays for Anti-Drug Antibody Detection • Labeling for Human Prescription D r u g a nd Biolog ic a l Pro duc t s Approved Under the Accelerated Approval Regulatory Pathway • Data Integrit y and Compliance W i t h C u r r e n t G o o d Manufacturing Practice • A d v e r s e Ev e nt R e p or t i n g for O ut s o u r c i n g Fa c i l it i e s Un d e r Section 503B of the Federal Food, Drug, and Cosmetic Act • ANDA Submissions–Content and Format of Abbreviated New Drug Applications • Elementa l I mpu r it ie s i n D r u g Products • Labeling for Biosimilar Products FDA Draft Guidances • D e v e l o p m e n t o f T h e r a p e u t i c Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations • N o n p r o p r i e t a r y N a m i n g o f Biological Products: Update • Q u a l i t y C o n s i d e r a t i o n s f o r Continuous Manufacturing • Competitive Generic Therapies • REMS Assessment: Planning and Reporting • B i o m a r k e r Q u a l i f i c a t i o n : Evidentiary Framework • New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2) • Pro duc t Ident i f ier s u nder t he Drug Supply Chain Security Act– Questions and Answers • Postapprova l Cha nges to Dr ug Substances Pending Guidances A list of the guidance documents FDA has planned for publication can be found at download.

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