Becker's Hospital Review

FDA forms ‘SWAT team’ to tackle orphan drug backlog

The Food and Drug Administration on Thursday shared a strategic plan to completely eliminate the agency’s backlog of orphan drug designation requests. The plan comes a week after FDA Commissioner ...
Food Safety News

FDA releases more inspection documents from ByHeart infant formula plants

FDA inspection documents reveal systemic contamination issues at ByHeart formula plant as botulism outbreak sickens 37 ...
JD Supra

FDA updates medical device user fee guidance for small businesses, tightening some rules for reductions and waivers

On July 31, 2025, the U.S. Food and Drug Administration (FDA) issued its final guidance document “Medical Device User Fee Small Business Qualification and Determination,” which supersedes its previous ...
FiercePharma

Under FDA scrutiny, Aurobindo's Eugia tallies a 5th Form 483 in less than a year

Eugia remains under FDA scrutiny as the unit of Indian drugmaker Aurobindo has received its fifth Form 483 since December. The company’s latest slap from the U.S. regulator stems from an April 25 to ...
NBC 10 Philadelphia

FDA Approves Drug for Rare Form of Lou Gehrig's Disease

Food and Drug Administration regulators on Tuesday approved a first-of-a-kind drug for a rare form of Lou Gehrig’s disease, though they are requiring further research to confirm it truly helps ...
JD Supra

FDA Inspection and Audits: What to Expect and How to Prepare

The Food and Drug Administration (FDA) is the federal agency charged with ensuring the safety of foods, medications and other consumer products sold in the United States. In carrying out its duties, ...
FierceBiotech

FDA to form advisory committee for digital health and AI

ANAHEIM, California—As more and more medical technologies are being built on artificial intelligence and machine learning, the FDA is enlisting a new panel of outside experts to help it get deeper ...
FiercePharma

Granules slammed in FDA warning letter detailing discarded documents, intruding birds at Indian plant

Shortly after making an M&A play to break into the CDMO business, Granules’ manufacturing bona fides have come under fire in a newly published rebuke by the U.S. FDA. In a warning letter dated Feb. 26 ...
Fox News

FDA approves drug treating rare form of Lou Gehrig's disease

Food and Drug Administration regulators on Tuesday approved a first-of-a-kind drug for a rare form of Lou Gehrig’s disease, though they are requiring further research to confirm it truly helps ...
kcra.com

Drug for rare form of Lou Gehrig's disease OK'd by FDA

Food and Drug Administration regulators on Tuesday approved a first-of-a-kind drug for a rare form of Lou Gehrig's disease, though they are requiring further research to confirm it truly helps ...
WHYY

Drug for rare form of Lou Gehrig’s disease OK’d by FDA

Food and Drug Administration regulators on Tuesday approved a first-of-a-kind drug for a rare form of Lou Gehrig’s disease, though they are requiring further research to confirm it truly helps ...