Latest Headlines

Latest Headlines

FDA announces new GDUFA fees and says to pay up by Oct. 1

The FDA has published its GDUFA facility fees for generic drugmakers for its next fiscal year, which are due on Oct. 1, in the Federal Register. Using formulas it lays out in the publication, the FDA says it ended up with a domestic API facility fee of $40,867 and foreign API facility fee of $55,867.

OraSure gets FDA nod for emergency use of rapid Ebola test

OraSure Technologies snagged the FDA's Emergency Use Authorization for its rapid Ebola test, a couple of months after the company got $10.4 million from the U.S. Department of Health and Human Services to develop its product.

Upstart gets $6M to back the first FDA-cleared OTC conception assistance device

Monroeville, PA-based startup Rinovum Women's Health has gained $6 million to back its commercialization efforts for its home-use conception assistance device that was cleared by FDA last fall. That's according to a SEC filing; the financing is an expansion of an infusion of just $700,000 it reported earlier this year.

In a big week for obesity devices, GI Dynamics terminates U.S. pivotal obesity device trial

One of a handful of obesity devices aiming for the U.S. market has been sidelined. Australian company GI Dynamics has opted, after discussions with the FDA, to terminate its pivotal trial for its EndoBarrier due to safety concerns. The trial had already been placed on hold by the agency in March due to the incidence of hepatic abscess.

FDA issues draft guidance on quality manufacturing metrics

Last January, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, initiated the Office of Pharmaceutical Quality. The idea is for it to work up guidelines that will push even reluctant drugmakers toward quality manufacturing and establish a risk-based method for setting inspections. The office is now providing an idea of how that will work.

Indian drugmaker in hot water with FDA over forged records

FDA investigators found a record-keeping mess at an Indian drug manufacturer that they say raises concerns about the quality of the active pharmaceutical ingredients that it shipped for use in U.S. drugs.

FDA launches probe into safety of common MRI contrast agent

Amid a growing body of research that shows deposits of gadolinium-based contrast agents (GBCAs) remain in the brain after repeat MRI procedures, the FDA is investigating the products' safety and risks.

FDA recall notice issued for nearly 2,000 Medtronic MiniMed insulin pumps

Medtronic disclosed difficulties with almost 2,000 units of its latest model insulin pump, the MiniMed 640G, which had been distributed in 10 European countries, according to a recall notice just made by the FDA. This model had its European launch in January and is slated for a PMA submission later this year.

Will marketing make the difference in approval of Sprout's 'pink pill' for women?

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.

Startup partners with AstraZeneca on smart inhalers ahead of Aussie IPO

Melbourne, Australia-based Adherium has pulled off a major pharma partnership just ahead of a proposed listing on the Australian Stock Exchange. It expects to list on Aug. 26, raising up to $35 million and at least $20 million. A new deal that the smart inhaler player just disclosed with AstraZeneca can only enhance its public market prospects.