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Nosch Labs, a maker of active pharmaceutical ingredients, was hit with a five-observation FDA Form 483 after workers at its Veliminedu Village, Chityal Madal, India, facility were observed passing off APIs that failed to meet quality control standards. Read More
Companies developing therapies that may have an adverse effect on the testes should conduct clinical trials to pin down the toxicity and whether it is reversible, the FDA says. Read More
A Jacksonville, Florida-based compounding pharmacy has agreed to pay $8.4 million to settle allegations that it billed the U.S. government for improper pain prescriptions, in violation of the False Claims Act. Read More
As lawmakers work to draft a Senate version of the 21st Century Cures Act, indications are that it will be much smaller than the massive FDA overhaul bill passed by the House, with reforms focused on just a handful of issues. Read More
Strengthening and exploring additional uses of the FDA’s Sentinel System will be a top priority of PDUFA VI, agency officials said during a Wednesday public meeting to kick off negotiations on reauthorization of the Prescription Drug User Fee Act. Read More
Mylan is continuing its recall of 14 lots of calcium chloride prefilled syringes that are incompatible with certain needleless adaptors, issuing a second letter in June after learning the product may still be on the market. Read More