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Beleaguered Indian generics maker Wockhardt is recalling 93,393 bottles of its blood pressure medicine Captopril in the U.S., after discovering the tablets failed to meet specification for thickness. Read More
Excipient makers preparing for the new GMP standard NSF/IPEC/ANSI 363 should be aware they are expected to police themselves to determine if they are meeting manufacturing requirements for their products. 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