BioPharm International - March 2021

BioPharm International - Regulatory Sourcebook - March 2021

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Page 38 of 47 eBook March 2021 BioPharm International 39 FDA 2021 Guidance Agenda Sees Focus on Generics The agency's focus appears to be on generic drugs for the upcoming year. F or the bio/pharmaceutical industry, 2020 was a challenging year, as it worked to develop a nd ma nu fac t u re v acc i ne s a nd t reat ments for t he COV I D -19 pa ndem ic. Despite a n inc reased work load a nd t ravel rest r ic t ions precipitated by the pandemic, FDA continued to meet goals and approve new drug products (1). As the effects of the pandemic continued in the f irst qua r ter of 2021, F DA's t wo bio/pha rma sectors, t he C enter for D r ug Ev a luat ion a nd R e sea rc h (CDER) and the Center for Biologics Evaluation and Research (CBER), have announced their g uidance agendas for the year. CDER has plans for new or updated guidance documents in a variet y of areas, especially for generic drugs and procedural updates (2); CBER is focused on tissues and advanced therapies (3). UPCOMING CDER GUIDANCE The 2021 guidance agenda for CDER includes more than 100 proposed guidance documents ranging from biosimi- lars, over-the-counter drugs, and compounded drug prod- ucts; to current good manufacturing practices (CGMP), pharmaceutical quality, chemistry, manufacturing, and con- trols (CMC); to clinical studies, animal rules, and toxicol- ogy. The bulk of the planned guidance for 2021, however, affect generic drugs and procedural considerations. CDER is planning 20 new or revised guidance docu- ments for generic drugs in 2021, with topics ranging from 180-day exclusivity to bioequivalence, to refuse-to-receive standards, and more. Some of the notable planned docu- ments include the following: • Pediatric Exclusivity General Considerations for [abbrevi- ated new drug applications] ANDAs thodonal - SUSAN HAIGNEY Regulatory Sourcebook Resources

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