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 ...
Becker's ASC

FDA Form 483 Outlines Conditions Observed at NECC

The FDA has released a copy of its Form 483, which outlines observed conditions at the New England Compounding Center in Framingham, Mass. The NECC is under investigation for contaminated products ...
Becker's ASC

FDA Forms Expert Panel to Speed up Device Approval

The U.S. Food and Drug Administration announced yesterday that it has formed a panel of experts to help understand new technology in medical devices, according to a Reuters report. The FDA hopes this ...