Bioanalytical Method Validation of ANDAs – What the Assessor Looks for During Inspections–6/17/19

Drs. Leah Falade and Suman Dandamudi from CDER’s Office of Generic Drugs discuss what to expect during FDA bioanalytical site inspections and how to be prepared. They also review aspects of FDA’s guidance on bioanalytical method validation and reviewers’ perspective on the assessment of bioanalytical data submitted in INDs, NDAs, ANDAs, and BLAs.

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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.

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