We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
A journal article asking the FDA to defy its own policies concerning mass compounding and drug importation to combat rising drug prices comes from an unusual source: the agency’s former second-in-command. Read More
The U.S. Department of Justice has filed an injunction to halt Dallas, Texas-based Downing Labs from manufacturing and distributing drugs until the compounder brings its operations into compliance with FDA regulations. Read More
A federal appeals court has ruled that Caraco Pharmaceutical Laboratories’ assumption that its plants wouldn’t be closed for GMP violations was not legal justification for it to skirt layoff-notice labor laws. Read More
Tuesday brought another setback for MannKind's Afrezza, with the company announcing that Sanofi will stop selling the rapid-acting inhaled insulin effective April 4, thus terminating a licensing deal the companies reached in 2014. Read More
The Senate HELP Committee has scheduled a Jan. 12 hearing to vote on the nomination of Robert Califf as the next FDA commissioner, a committee spokesman told DID. Read More
The FDA has slapped India's Cadila Pharmaceuticals with a warning letter for GMP violations — including a lack of quality controls, improper recordkeeping and inadequate investigations — at its Moraiya formulation plant and Ahmedabad API facility. Read More