Pharmaceutical Technology - March 2021

Pharmaceutical Technology - Regulatory Sourcebook - March 2021

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6 Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2021 P h a r mTe c h . c o m Quality F or the bio/pharmaceutical industry, 2020 was a challeng- ing year, as industry worked to develop and manufacture vaccines and treatments for the COVID-19 pandemic. Despite an increased workload and travel restrictions precipitated by the pandemic, FDA continued to meet goals and approve new drug products (1). As the effects of the pandemic con- tinued in the first quarter of 2021, FDA's two bio/pharma sectors, the Center for Drug Evaluation and Research (CDER) and the Cen- ter for Biologics Evaluation and Research (CBER), have announced their guidance agendas for the year. CDER has plans for new or updated guidance documents in a variety of areas, especially for generic drugs and procedural updates (2); CBER is focused on tis- sues and advanced therapies (3). Upcoming CDER guidance The 2021 guidance agenda for CDER includes more than 100 pro- posed guidance documents ranging from biosimilars, over-the- counter drugs, and compounded drug products; to current good manufacturing practices (CGMP), pharmaceutical quality, chemistry, manufacturing, and controls (CMC); to clinical studies, animal rules, and toxicology. The bulk of the planned guidance for 2021, however, affect generic drugs and procedural considerations. CDER is planning 20 new or revised guidance documents for ge- neric drugs in 2021, with topics ranging from 180-day exclusivity to bioequivalence, to refuse-to-receive standards, and more. Some of the notable planned documents include the following: • Pediatric Exclusivity General Considerations for [abbreviated FDA 2021 Guidance Agenda Sees Focus on Generics Susan Haigney The agency's focus appears to be on generic drugs for the upcoming year. THODONAL - STOCK.ADOBE.COM

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