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FDA

Latest Headlines

Latest Headlines

Pozen gets a second CRL as its API supplier awaits FDA reinspection

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."

Sanofi's newly approved intradermal quadrivalent Fluzone forgoes the shot

The FDA approved Sanofi's Fluzone Intradermal Quadrivalent in adults age 18 through 64.

FDA approves diagnostic to spot blood cancer-causing virus

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 launches point-of-care, PCR molecular diagnostic system from $450M deal for iQuum

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 nabs FDA 'breakthrough' tag for diabetic eye disease

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.

FDA took a back seat in morcellator regulation, researchers say

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.

FDA clears laser-based comb to combat hair loss

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 heads to the FDA with its $1B rare disease drug

Jazz Pharmaceuticals has kicked off a rolling FDA submission for defibrotide, a rare disease treatment acquired in its $1 billion buyout of Gentium.

FDA works to improve medical device approval times

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.

FDA offers guidance as track-and-trace rules loom

With the deadline for new track and trace requirements kicking in January 1 for drugmakers and wholesalers, the FDA has issued new guidance to help them understand what they are up against. According to Regulatory Focus, the agency has issued draft guidance on what information companies are supposed to exchange under the Drug Quality and Security Act (DQSA), which Congress passed last year.