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Biologics

FDA Panel to Mull Covid Vaccine Strain Selection

FDA announces a 5/22 Vaccines and Related Biological Products Advisory Committee meeting to discuss and make recommendations on the selection of the 2...

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More Unannounced Foreign Inspections Coming

FDA says it is expanding the use of unannounced inspections of foreign medical product and food manufacturing facilities.

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Human Drugs

FDA Ordered to Speed U.S. Drug Manufacturing

President Trump signs an Executive Order requiring FDA to take steps to increase domestic drug manufacturing.

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FDA General

Vinay Prasad Tapped as New CBER Director

FDA appoints University of California, San Francisco professor Vinay Prasad to serve as CBERs new director, replacing Peter Marks, who abruptly resign...

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FDA General

BIMO Inspection e-Submission Requirements Outlined

An FDA Webinar discusses drug study information in NDAs/BLAs that will need to be electronically submitted in a certain format to assist FDA in planni...

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FDA General

FDA Cancels Union Session on Layoffs

FDA cancels a scheduled meeting with the National Treasury Employees Union, which represents thousands of FDA staff, to discuss the impact of layoffs ...

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Human Drugs

RM Pharma Gains Low-Dose HemiClor Approval

FDA approves an RM Pharma 505(b)(2) for HemiClor (12.5 mg chlorthalidone) tablets for treating hypertension in adults.

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Biologics

Clinical Trials for Covid Boosters: Makary

FDA commissioner Martin Makary reiterates that he wants to see clinical trials for new Covid vaccine boosters.

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Medical Devices

Teleflex Gains Expanded Use on QuikClot Device

FDA clears a Teleflex 510(k) for an expanded indication for its QuikClot Control+ Hemostatic Device to include all grades of internal and external ble...

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Human Drugs

Amicis Research Didnt Follow Investigation Plan: FDA

FDA warns Dr. Nana Barseghian about a bioresearch monitoring violation in a clinical trial at Northridge, CA-based Amicis Research Center.