Saturday, August 30, 2008

New FDA Guidance - Residual Solvents in Drug Products

This just out from the FDA, a new guidance document entitled, "Guidance for Industry - Residual Solvents in Drug Products Marketed in the United States." (PDF) Here's what it's all about . . .
  1. How holders of new drug applications (NDAs) or abbreviated new drug applications (ANDAs) for compendial drug products should report changes in chemistry, manufacturing, and controls (CMC) specifications to FDA to comply with the USP’s General Chapter <467> "Residual Solvents" and 21 CFR 314.70
  2. How manufacturers of compendial drug products that are not marketed under an approved NDA or ANDA can comply with the new <467> and the Federal Food, Drug, and Cosmetic Act (the Act)

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1 comment:

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