GAO Report Says FDA Needs Better Oversight for Expedited Applications
A recent report by the United States Government Accountability Office to the Ranking Member, Subcommittee on Labor, Health and Human Services, Education and Related Agencies, Committee on Appropriations, House of Representatives reviews expedited drug approvals. GAO evaluated the number of new drugs approved through an expedited … [Read more...] about GAO Report Says FDA Needs Better Oversight for Expedited Applications
Sweet Leaf Recalls Teas in Glass Bottles for Possible Glass Fragments
On December 10, the Sweet Leaf Tea Company announced a voluntary recall of Sweet Leaf Tea in 16-ounce glass bottles because of the possible presence of glass fragments. This was the result of glass breakage during the filling process. Consumers could be cut or injured if they ingest glass fragments. The company has received four … [Read more...] about Sweet Leaf Recalls Teas in Glass Bottles for Possible Glass Fragments
Invokana Increases Risk of Bone Fractures, FDA Warns
The Food and Drug Administration (FDA) issued a safety announcement in September warning patients and health care providers of an increased risk of bone fractures in patients taking the type 2 diabetes drugs Invokana and Invokamet (canagliflozin). The FDA deemed the new safety announcement necessary because bone fractures have … [Read more...] about Invokana Increases Risk of Bone Fractures, FDA Warns
CarMax Accused of Selling Cars with Lethal Safety Defects; Senator Seeks Tighter Regulation
U.S. Sen. Richard Blumenthal has proposed new legislation to regulate the sale of used cars with unrepaired recalls with what he says can be lethal safety defects. Blumenthal, the senior senator from Connecticut, is concerned about cars sold by CarMax. "CarMax advertises that all its vehicles must pass a rigorous '125 point … [Read more...] about CarMax Accused of Selling Cars with Lethal Safety Defects; Senator Seeks Tighter Regulation
FDA Turns Down Petition to Ban Transvaginal Mesh
Transvaginal mesh implants have been fraught with safety concerns in recent years. The U.S. Food and Drug Administration (FDA) has rejected a petition to ban transvaginal mesh implants, which have been fraught with safety concerns in recent years. The petition, which was filed in 2011, urged the agency to remove all … [Read more...] about FDA Turns Down Petition to Ban Transvaginal Mesh
