CDER’s Office of Pharmaceutical Quality’s Savan Khanna presents the OPQ Integrated Quality Assessment (IQA) process for Abbreviated New Drug Applications (ANDA). He provides insight into the roles and responsibilities of team members involved in the assessment of the ANDA. Additionally, he provides a brief overview of the assessment process timeline and changes that have happened since the initiation of the IQA process.

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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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