Docket Number: FDA-2021-D-1139 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended for sponsor-investigators (hereafter referred to as sponsors) developing […]
Docket Number: FDA-2019-D-1615 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research This guidance provides recommendations for developing the content and format of a […]
Delivery Method: VIA UPS Product: Animal & VeterinaryDrugs Recipient: Recipient Name Steven R. Kanz Recipient Title President Lewiston Feed & Produce Company 105 E. Main StreetLewiston, […]
Delivery Method: Via Email Delivery Confirmation Product: Drugs Recipient: Recipient Name Clayton McGhan, MHA Recipient Title Interim West Hawaii Regional CEO Hawaii Health Systems Corporation dba […]
Summary Company Announcement Date: July 13, 2022 FDA Publish Date: July 13, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential presence of visible […]
CDER, CBER and CDRH Expanded Access INDs and Protocols (2016-2020) On this page you will find: The Center for Drug Evaluation and Research (CDER) and the […]
FDA’s Compounding Incidents Program aims to help protect the public against poor quality compounded drugs through surveillance and review of complaints, which include adverse event and […]
CDER professionals participate in several meetings, conferences and workshops throughout the year. Appealing primarily to the pharmaceutical industry and health care professionals, topics can range from users […]
Image Don’t Fall for False Claims When you’re browsing, one of the best ways to protect yourself from fake, and even possibly harmful, products is asking […]
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