The FDA has slammed generic drug maker Hetero Labs with a Form 483 after an inspection of one of its warehouses in India ...
The US drug regulator has turned its lens on Hetero, issuing back-to-back Form 483s to its API Unit 9 and warehouse in ...
GAINESVILLE, Fla., Oct. 28, 2025 (GLOBE NEWSWIRE) -- NeXtGen Biologics announced today the successful completion of a two-day ...
In a startling observation that raises major questions about compliance and product safety, the U.S. Food and Drug ...
Key market opportunities in dissolution testing include optimizing drug bioavailability and enhancing quality control to meet regulatory demands. Understanding scientific principles and regulatory ...
More than a hundred E. coli cases were linked to contaminated onions produced by Taylor Farms used in McDonald's burgers.
The FDA has released a copy of its Form 483, which outlines observed conditions at the New England Compounding Center in Framingham, Mass. The NECC is under investigation for contaminated products ...