The FDA issued a warning against unnecessary and excessive fetal ultrasound imaging and heartbeat monitoring using Doppler heartbeat monitors, advising women not to receive or perform the procedures at home or for nonmedical reasons.
Drugmaker Pozen says its API supplier has done everything the FDA asked after noting issues in an April plant inspection and the company resubmitted its application in July. But the FDA's compliance division has been too busy to get back to the plant and see for itself, and so the agency has sent Pozen a second CRL with "identical wording."
The FDA approved Sanofi's Fluzone Intradermal Quadrivalent in adults age 18 through 64.
Santa Ana, CA-based MP Biomedicals has nabbed FDA approval for the first supplemental test designed to better identify blood donors that have tested positive for human T cell lymphotropic virus.
Roche has launched the Laboratory-in-a-tube technology it acquired when it bought iQuum in April for $275 million up front and up to $175 million in milestone payments. Roche is making the system available in the U.S. and Europe.
Roche's Lucentis may now have a bigger jump on Eylea in diabetic retinopathy. The Swiss drugmaker's Genentech unit won the FDA's "breakthrough" designation for that indication on Monday. And Lucentis was already on the FDA's priority review track, with a decision date in February.
Weeks after the FDA recommended against using laparoscopic power morcellator tools for the "majority" of women undergoing certain gynecological procedures, researchers and industry professionals are shedding light on how the agency first approved the products and illustrating potential flaws in device regulation.
The FDA has just cleared two new phototherapy devices manufactured by Lexington International under the brand HairMax for the treatment of hereditary hair loss.
Jazz Pharmaceuticals has kicked off a rolling FDA submission for defibrotide, a rare disease treatment acquired in its $1 billion buyout of Gentium.
Deputy director for science at the FDA's Center for Devices and Radiological Health, Bill Maisel, addressed the issue of long approval trials in a speech at Cambridge yesterday.