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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
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
The head of CDER’s Office of Compliance is removing herself from all substantive policy decisions after her husband became part-owner in a law firm with pharmaceutical clients. Read More
The FDA has underestimated the burden that would be imposed on drug manufacturers in collecting and reporting quality metrics data, industry says in comments on the agency’s quality metrics draft guidance. Read More
A Los Angeles area supplement provider has been hit with an FDA warning letter for selling unapproved drugs for conditions ranging from kidney stones to stroke prevention. Read More
Nearly a dozen organizations are calling for clarification on a draft FDA plan to label injectable therapies that are meant to be used multiple times by a single patient as products for “single patient–use.” Read More