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 ...
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 ...