FDA Related News

Biologics

White House Relents on FDA Covid-19 Guidance

The White House buckles under behind-the-scenes FDA resistance and allows the agency to post a controversial guidance that outlines stricter requireme...

Human Drugs

Fee Rate for FT 2021 Rare Pediatric Disease Voucher

Federal Register notice: FDA announces the fee rate for using a rare pediatric disease priority review voucher for fiscal year 2021.

FDA General

Workshop on Sentinel System Surveillance

FDA and Duke Universitys Margolis Center for Health Policy plan a 10/14 annual Sentinel Initiative public workshop.

Human Drugs

CGMP Issues at LEC Custom Products

FDA warns Canadas LEC Custom Products about CGMP violations in the production of finished drugs at one of its manufacturing facilities.

Human Drugs

Consider Alternate Interchangeability Methods: Study

Researchers say sponsors seeking an interchangeable designation for a biosimilar should consider alternate approaches that will meet FDA expectations....

Human Drugs

Essential Pharmaceutical Adulterated, Misbranded Supplements

FDA warns Essential Pharmaceutical about multiple violations in its production of dietary supplements.

Not Enough Done on FDA Hiring, Retention: PhRMA

PhRMA calls on FDA to take more action to meet its hiring and retention goals in the current PDUFA and BsUFA cycles.

Medical Devices

Biosense Websters Ablation Catheter Approved

FDA approves Biosense Websters Thermocool SmartTouch SF Ablation Catheter for treating persistent atrial fibrillation.

Medical Devices

FDA Seeks Electronic Premarket Submissions Pilot Volunteers

FDA issues a call for volunteers to pilot electronic delivery of premarket submissions during the Covid-19 pandemic.

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that include Essential Pharmaceutical and LEC Custom Products.