Regulator Spotlight
At the AAM Generics and Biosimilars Conference, held in Maryland in October 2024, CDER Principal Deputy Director Jacqueline Corrigan-Curay reviewed the regulatory landscape for generics and biosimilars, describing the current state of play and outlining future CDER priorities and goals. She addressed: ● FY 2024 highlights for CDER’s generics drug program, including GDUFA and other commitments ● FY24 highlights for the biosimilars program, including BsUFA innovations, and ● quality management, compliance and supply chain concerns.
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ABOUT THE WEEKLY SUPPLEMENT
Along with a feature story on a presentation or panel discussion at a recent conference in which leading regulators address the challenges and developments in a key area of concern, our Weekly Supplements include a summary listing of the “Updates in Brief,” drug GMP warning letters and recalls, and EMA non-compliance reports that have been posted on IPQ’s website during the week. Subscribers can then click through to the full posting.
Also provided, where applicable, are links to the parts of in-depth stories and Monthly Updates that have been released during the week.
Appended to the issue is a chronological listing of the headlines of the featured regulator stories since IPQ began its Weekly Supplement series in February 2024. Also appended are the headlines of the in-depth stories that IPQ has released since 2020. Those of especially high relevance to the regulator insights provided in this issue are indicated with a red star. Click on the headlines to access the stories.