Guideline on the Preparation of Investigational New Drug Products (Human and Animal)

• Date: February 10, 2011
• Source: www.fda.gov

This guideline informs interested persons on certain practices and procedures for the preparation of investigational new drug products for human and animal use that may be useful to persons seeking to comply with certain sections of the current good manufacturing practices (CGMP) regulations for finished pharmaceuticals (Title 21 of the Code of Federal Regulation, Parts 210 and 211)

 

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