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The agency’s focus appears to be on generic drugs for the upcoming year.
For the bio/pharmaceutical industry, 2020 was a challenging 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. As the effects of the pandemic continued in the first quarter of 2021, FDA’s two bio/pharma sectors, the Center for Drug Evaluation and Research (CDER) and the Center 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; CBER is focused on tissues and advanced therapies.
Susan Haigney is managing editor of Pharmaceutical Technology.
eBook: Regulatory Sourcebook, March 2021
When referring to this article, please cite it as S. Haigney, “FDA 2021 Guidance Agenda Sees Focus on Generics," Pharmaceutical Technology Regulatory Sourcebook eBook (March 2021).