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A Montana compounder was hit with a 17-observation Form 483 due to issues with its sterile processing, contamination controls and other GMPs. Read More
Amgen is reporting a “clinically meaningful number” of patients showed complete remission in a Phase 2 study of its pricey drug to treat a rare strain of leukemia. Read More
In a bipartisan 28-2 vote, the Senate Appropriations Committee Thursday approved the fiscal year 2016 appropriations bill to fund the FDA, but at levels far below what President Barack Obama had requested. Read More
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