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Last Updated: October 3, 2026
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This presentation covered GDUFA-III implementation updates related to Mahesh Ramanadham and Derek Smith, CDER Office of Pharmaceutical Quality, note that during the COVID-19 public health ... Rakhi Shah, CDER Office of Pharmaceutical Quality, discusses integrated manufacturing (process & Aditi Thakur from CDER's Office of Pharmaceutical Quality and Tara Gooen Bizjak from CDER's Office of Compliance discuss ... This presentation described the purposes, focuses, and types of clinical investigator (CI) During this public meeting, FDA, sponsor companies, and other experts explores the root causes of Complete Responses (CRs) ... This presentation addressed nitrosamine formation and their presence in drug products, referencing relevant FDA guidances. This presentation explored the Generic Drug Science and Accessibility-Bioequivalence (GDSA-BE) initiative and its role in ... Laurie Graham, Director for the Division of Internal Policies and Procedures, discusses
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