Robert F Kennedy Jr’s quest to head the nation’s largest healthcare agency cleared a major hurdle Tuesday, as the Senate Finance Committee voted along party lines […]
Docket Number: FDA-2011-D-0694 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance is intended to assist […]
Docket Number: FDA-2008-D-0386 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research The development safety update report (DSUR) […]
Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This document provides guidance to sponsors planning to file […]
(Reuters) – A medical advocacy group on Tuesday sued the main U.S. health agencies over the sudden removal of websites containing public health information in response […]
Docket Number: FDA-2019-D-4964 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This document is intended to provide […]
Docket Number: FDA-1998-D-0278 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The National Environmental Policy Act of […]
Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Jason McGuire Recipient Title Senior Vice President, Operations Fagron Compounding Services, LLC dba Fagron Sterile Service […]
Delivery Method: Via Electronic Mail – Delivery and Read Receipt Requested Reference #: 320-25-30 Product: Drugs Recipient: Recipient Name Mr. Arif Vazirally Recipient Title Executive Chairman […]
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