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www.biopharminternational.com 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 - Stock.adobe.com SUSAN HAIGNEY Regulatory Sourcebook Resources