FDA Issues Guidance on Drug Validation Data

The FDA July 24 released a guidance for industry on how to submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity and potency of drug substances and drug products.

The recommendations in the guidance apply to new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs) and supplements to these applications, the Food and Drug Administration said. The principles in the guidance also apply to Type II drug master files.

A drug master file (DMF) is a submission to the FDA that may be used to provide confidential, detailed ...