June 28, 2024
Baylor St. Luke’s Medical Center, Baylor College of Medicine (BCM), and Surgical Associates of Texas PA have jointly agreed to pay $15 million to resolve claims […]
June 28, 2024
Approved Active Moieties to which FDA has issued a Written Request for Pediatric Studies under Section 505A of the Federal Food, Drug, and Cosmetic Act NOTE: This list simply identifies […]
June 28, 2024
FOOD AND DRUG ADMINISTRATION MODERIZATION ACT OF 1997 [Page 111 STAT. 2296] Public Law 105-115 105th Congress SEC. 127. APPLICATION OF FEDERAL LAW TO PRACTICE OF […]
June 28, 2024
The US Surgeon General has called for a warning label on social media platforms, citing research that points to a link between social media use and […]
June 28, 2024
Submit Comments by 09/29/2024 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]
June 28, 2024
LYON, France — The first oral small molecule anti–proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor appears to be effective in not only lowering low-density lipoprotein […]
June 28, 2024
The prevalence of vision-threatening retinopathy in people with diabetes has increased exponentially in the past decade, most acutely among younger adults and Hispanic and Black populations, […]
June 28, 2024
Below are frequently asked questions and the associated answers sorted by topic area. Drug Review What information and types of notifications are provided to sponsors during […]
June 28, 2024
VIENNA — People with spondyloarthritis (SpA) who have low or stable disease activity can effectively and safely be managed using a model of patient-initiated care with […]
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