With FDA’s new regulation of laboratory developed tests (LDT) that becomes effective July 5, the agency has issued a final guidance intended to help small entities comply. Source: Drug Industry…
The United States Pharmacopeia (USP) and the FDA are working together to promote opportunities for sponsors to develop new generic medications for off-patent drugs that currently lack an approved generic…
In this edition of Quick Notes, Akili snags approval for a video game-based ADHD treatment, Johnson & Johnson’s orthopedics unit wins FDA authorization for a partial knee replacement robotic-assist system,…
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws…
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…