In the next few weeks, the FDA will rule again on a prescription treatment for female sexual dysfunction. This is the third time the FDA has considered Sprout Pharmaceuticals' drug flibanserin, which has been rejected twice. This time, however, it has its best chance yet of getting approved, having already gained an FDA advisory panel nod in June.
The FDA has approached Google for help identifying adverse drug events in search data. The regulator hooked up with Google to access the insights of Evgeniy Gabrilovich, an engineer at the tech behemoth who has published papers on the subject of mining search queries for adverse event reports.
Talib Khan is already doing time in federal facility in Philadelphia, but the FDA has let him know that once he is out, he is barred from ever working for any company that sells FDA-approved drugs.
India's troubles with pharmaceutical manufacturing widened this week as the U.S. FDA issued an import alert for the Emcure Pharmaceuticals plant in Hinjawadi, citing deficiencies in good manufacturing practices at the site with no specifics immediately available.
Anacor Pharmaceuticals' topical treatment for eczema easily beat placebo in two Phase III trials, sending the biotech's share soaring and setting the stage for FDA application in the first of half of 2016.
Vice President Joe Biden weighed in with the Chinese on FDA's efforts to negotiate an agreement to bump up its inspection staff in the country. So did former FDA Commissioner Margaret Hamburg. But it is locally employed FDA staffer Lixia Wang who has won the prize, in part for her efforts to help seal the deal.
Most FDA warning letters are about problems that inspectors have found during visits to plants that manufacture APIs or finished formulations, and they generally will mean cash outlays for companies as they deal with the issues at hand. But sometimes, the letters are just for cash.
The Center for Drug Evaluation and Research, or CDER, is the FDA's OTC and prescription drug watchdog. Efficacy and safety are the names of its game. But someone has to look after drug market--and that would be the Office of Prescription Drug Promotion (OPDP), probably best-known as the distributor of the dreaded untitled and warning letters that inspire trepidation among pharma marketers.
Pfizer just announced that the FDA agreed to review a daily, 11-milligram modified-release tablet of its rheumatoid arthritis drug Xeljanz for patients who don't respond adequately to methotrexate (marketed as Rheumatrex and Trexall).
A congressman is taking aim at perceived flaws in FDA's long-awaited, much-discussed guidance on the use of Twitter.