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The project will focus on modernizing the agency’s regulatory processes and reducing the time, cost and uncertainty of bringing a product to market. Read More
A complaint about ineffective erectile dysfunction drugs led to an FDA inspection of a Texas-based compounder, resulting in a lengthy warning letter from the agency detailing sterility concerns. Read More
The FDA approved the most generic drugs during May and June that is has since it began tallying approvals, according to the agency’s latest report on the generics program — helping Commissioner Scott Gottlieb make good on his early-tenure promises to speed generics to market in an effort to lower U.S. drug prices. Read More
At a meeting on opioids abuse, FDA Commissioner Scott Gottlieb announced that the agency will expand its REMS requirements for extended-release and long-acting opioids to the manufacturers of immediate-release formulations — which account for 90 percent of the opioid painkiller prescriptions written each year in the U.S. Read More
Though glutamine is currently sold as a nutritional supplement and a medical food, Emmaus’ L-glutamine will be produced and sold as a prescription drug. Read More
A Chinese heparin contract testing lab has been warned by the FDA for significant cGMP violations, recalling unresolved questions and concerns from the Chinese heparin scandal a decade ago. Read More
The FDA will give manufacturers an extra year before it begins enforcing new requirements for individual serial codes in drug packaging, according to a new draft guidance. Read More