Speed of FDA approvals a starting point for new Congressional review
FDA approvals are going to remain an issues for medical device manufacturers. Congressional leaders reviewing the Medical Device User Fee and Modernization Act say recent reforms have been overstated and that concerns over safety and increased scrutiny are wrongheaded.

FDA Pains Migraine Sufferers
Roughly 30 million Americans suffer from painful and often disabling migraine headaches.

FDA Grants PharmaJet 510(k) Clearance On Intradermal Needle-Free Injection Device
The U.S. Food and Drug Administration (FDA) has awarded PharmaJet 510(k) clearance to market a 0.1mL Intradermal (ID) Needle-free Injection System. Delivery to the intradermal tissue layer is the approach used for many vaccines, such as tuberculosis and rabies, for which ID delivery has proven efficacious. In addition, ID delivery is being explored for vaccines such as polio, influenza and many ...