Resource Capacity Planning and Modernized Time Reporting

Drug Trials Snapshots: breaking down the what, how and why. Drug Trials Snapshots is part of an overall FDA effort to make demographic data more available and transparent.

The U.S. Food and Drug Administration (FDA) is warning that cases of a rare but serious infection of the genitals and area around the genitals have been reported with the class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors.

The Food and Drug Administration is advising consumers not to purchase or use Umovy, a product promoted and sold for joint pain on various websites, including www.umovy-usa.com, and possibly in some retail stores.

CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug

In accordance with section 505A(e)(1) of the Act, as amended by FDAAA (Pub. L. No. 110-85), the following list identifies those approved drugs for which a pediatric exclusivity determination was made, on or after September 27, 2007.

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program.