FDA Law Blog

JULY 29, 2024

By John W.M. Claud — There is a growing consensus among legal experts that after Loper Bright, FDA may rely on non-binding guidance to instruct industry with hopes of charting regulatory pathways that avoid litigation. In areas like biologics, biosimilars, and interchangeable biosimilars, where emerging technologies meet regulatory complexities, this is perhaps a wise strategy.

Manufacturing 64

Manufacturing Complication Government IT 64

PEMBlog

JULY 29, 2024

Dog bites are unfortunately common in the Emergency Department. Remembering which ones to suture for cosmetic concerns while assuring we reduce the risk of infections is important. Also, most should get antibiotics. Which one? Dogmentin! (It’s a portmanteau of Dog and Augmentin)… Lyrics What you’re hearin’ is true, dog bites on the rise Take a big chunk outta hands face or thighs Animal safety prevention 101 cuddly puppies can still bring us fun But if kids are bitten we

Medical 52

Medical Utilities Management IT 52

FDA Law Blog

JULY 29, 2024

By Jennifer D. Newberger — In November 2023, FDA published a proposed rule regarding wound products containing antimicrobials. From a legal perspective, the reason for the proposed rule is that these wound products are some of the few remaining medical devices that have not yet been classified by FDA. As a result, they have been coming to market through the 510(k) process as Class II medical devices since passage of the Medical Device Amendments, nearly 50 years ago.

Specialization 64

Specialization Medical Provider IT 64