Health Affairs20h
Fosamax Lawsuit: The Importance Of State Duties To Warn Of Drug Dangers
Fosamax further defines the obligation of drug manufacturers to present clear, unambiguous, and accurate information to the ...
Fierce Pharma1d
South Africa's Aspen hit with warning letter chiding the continent's largest drugmaker over sterility issues
After rising to prominence during the COVID-19 pandemic, South African drugmaker Aspen Pharmacare has landed in the FDA's ...
Scientist whose work led FDA to ban food dye says agency overstated risk
When the FDA announced in January, before President Joe Biden's term ended, that it would ban a dye called red dye No. 3 in ...
BioWorld3d
FDA hits Q’Apel Medical with warning for design changes to Hippo
The U.S. FDA warning letter to Q’Apel Medical Inc., of Fremont, Calif., lists several deviations from the regulation, but the ...
Becker's Hospital Review4d
FDA warns Dexcom over 2 site deficiences
Dexcom, a medical device manufacturer that develops continuous glucose monitoring systems, received a warning letter from the FDA regarding manufacturing processes at its facilities in San Diego and ...
Hemp Gazette4d
US FDA Targets Injectable CBD Firm
A company promoting an intravenous form of cannabidiol (CBD) has been sent a warning letter from the U.S. Food and Drug ...
Healio4d
Societies take stand against off-brand GLP-1s over safety concerns
A rise in the use of non-FDA-approved diabetes and obesity medications has spurred health care professionals and medical ...
Dexcom receives FDA warning letter for 2 manufacturing sites
Dexcom, the local maker of continuous glucose monitors, received a warning letter from the Food and Drug Administration last ...