The FDA has made modifications to the standards the agency uses for premarket reviews of medical devices. Source: Drug Industry Daily

Parameters for slowing or blocking an FDA drug or device inspection are now available to manufacturers and storage facilities, following the agency’s release of its final guidance on the subject…

The war against fake GLP-1 inhibitors is heating up, with Eli Lilly filing six suits against med spas and wellness centers selling unapproved versions of its patented tirzepatides — Mounjaro…

An inspection of the Dr. Reddy’s Laboratories Andra Pradesh, India, facility two weeks ago brought the company yet another Form 483, this time for a lack of valid testing, failure…

This edition of Quick Notes focuses on FDA approvals for expansion of the age allowed for a treatment for muscular dystrophy, an expanded age indication of an RSV vaccine, a…

This week, the FDA published a final rule on medical gases. Final guidance was issued on circumstances that constitute delaying, denying, limiting, or refusing a drug or device inspection. Final…

The FDA’s draft guidance on real world evidence (RWE) for non-interventional studies is too high level and lacks enough detail to guide the drug and biologics industry which limit its…

Intensive sessions of behavioral modification — not weight loss drugs — are the best way to treat children and teens who are overweight or obese, according to new treatment recommendations…

The FTC submitted comment supporting the US Patent and Trademark Office (USPTO) April proposed rule that seeks a variety of changes to the Patent Trial and Appeal Board (PTAB) proceedings…

The FDA’s draft guidance on interchangeability describes considerations for switching studies to support a product as interchangeable with a reference product, given the limited risk the FDA has seen in…