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FDA Regulatory Requirements for Clinical Investigators and Case Examples (9of14) REdI 2018
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CDER’s Faranak Jamali notes that clinical investigators are among the most commonly inspected entities in CDER-regulated studies. Jamali provides discusses clinical investigator’s responsibilities and potential inspectional findings during the conduct of the clinical investigations.
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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.
Phone: (301) 796-6707 I (866) 405-5367
_______________________________
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
Phone: (301) 796-6707 I (866) 405-5367