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This presentation outlined changes in GDUFA III and described types of This presentation addressed nitrosamine formation and their presence in The second of four Q&A discussion panels for day two of the Generic This presentation explained the rationale and importance of excipient safety evaluation in pediatric populations for generic drugs. The first of three Q&A discussion panels for day one of the Generic The third of four Q&A discussion panels for day two of the Generic This presentation covered GDUFA-III implementation updates related to facility assessments, including pre-submission facility ... This presentation provided an overview of the FDA Product-Specific Guidance (PSG) Program and explained its background and ... The Generic Drugs Forum is an annual, two-day event with the goal of providing practical regulatory information to aid prospective ... The second of three Q&A discussion panels for day one of the Generic This presentation reviewed the comparative analyses (CA) process and provided
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