IBM's artificial intelligence tool Watson is an expert at Jeopardy, but it can't answer the question as to whether the technology should be regulated as a medical device. That decision rests with Congress and the FDA, or perhaps lobbyists.
The FDA issued an administrative order requiring PMA approval for new and existing automated external defibrillators, citing manufacturing issues and pointing to the recall of 2 million of the devices since 2005 as justification for the more stringent regulation.
European regulators have joined the FDA in suggesting joint plant inspections and training with their Indian counterparts. The offers come as India's industry has lost status in recent years as the FDA and other countries have banned Indian plants from shipping to the U.S. and Europe over quality and data-integrity issues.
The FDA has banned imports to the U.S. from another Indian drugmaker, adding to a substantial list of Indian companies whose drugs are now prohibited from being sold in the U.S.
For 9 months AstraZeneca has had the sales of its blockbuster heartburn drug Nexium protected by a bureaucratic dam that has kept generics from getting to market. But the agency opened the floodgates today, approving a copy from Teva Pharmaceutical Industries of the $3 billion seller.
FDA Commissioner Margaret Hamburg appointed a Duke cardiologist with ties to biopharma as the agency's deputy commissioner for medical products and tobacco, stoking speculation that she's lining up a successor.
Celator Pharmaceuticals received fast-track designation for its candidate for the treatment of secondary acute myeloid leukemia in elderly patients. CPX-351 is designed to achieve sustained release of the anticancer drugs cytarabine and daunorubicin in a precise ratio.
The FDA said in a draft guidance issued last week that it does not intend to regulate general wellness products, which include an array of consumer-oriented wearables like Fitbit's exercise trackers.
An Apotex plant in Brantford, Ontario, was cited in a November inspection for equipment that was not properly cleaned and was found to be contaminated, according to a report in The Star. The plant was also cited for not having password-protected computers that could prevent employees from altering or deleting testing data.
Dozens of angry patients who claim they were injured by LASIK eye surgeries are banding together in an attempt to pressure the FDA to crack down on providers of the therapy.