Analytical procedures are critical to the assurance of the quality of new pharmaceuticals that are to be placed on the market.  The information that should be submitted to the FDA is governed by the Food, Drug, and Cosmetic Act, Title 21 of the Code of Federal Regulations, and various guidances.  This talk will focus on these requirements and recommendations.  In addition blinded examples of the type and amount of information supplied and the FDA review process will be discussed.

Analytical procedures and the regulation of new drug development

244th National Meeting (2012)

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