483
Pharmacyclics LLCPharmacyclics LLC – FDA 483, Apr 27, 2022
Record Details
Pharmacyclics LLC in South San Francisco, CA, received a Form FDA 483 with two observations following an inspection. The firm failed to provide written IND safety reports to participating investigators regarding potential serious risks associated with an investigational product. Additionally, the company did not adequately describe all transferred obligations to its Contract Research Organization, specifically concerning the return and disposition of study drugs.
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ID · 13d32dfd-1ab9-4ca3-89ec-acf12f21e6aa
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