CDER’s Hanan Ghantous discusses PINDs, INDs and NDAs/BLAs, and the FDA’s roles and responsibilities related to nonclinical safety assessment (pharmacology/toxicology) in detail. He provides case studies and a comparison of the development of biologic drugs vs. small molecule drugs will be presented.
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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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