Fda Breakthrough Medicines; Have They Caused Breakthrough Headaches for Hta Agencies?

New FDA breakthrough-drug category--implications for patients.

U.S. pharmaceutical regulations are based on the principle that patients should not be exposed to new prescription drugs until their efficacy and safety have been shown. Since 1962, the Food and Drug Administration (FDA) and Congress have balanced the efficient review of investiga­ tional drugs with the need to withhold judgment until sufficient evidence is available to clarify the benefit–risk...

Breakthrough cure (for mice)

Many a science writer has fantasized about capping a story with the headline “Good News for Sick Mice!” One of the toughest struggles is deciding how to cover a story that has produced tantalizing, even amazing, results in laboratory animals but could well be a total bust by the time it gets to humans. That issue came up in early July, when Elan Pharmaceuticals, an Irish company with laboratori...

Breakthrough : Thrombosis –

Prospects for Breakthrough Propulsion from Physics Prospects for Breakthrough Propulsion from Physics Prospects for Breakthrough Propulsion from Physics

“Space drives,” “Warp drives,” and “Wormholes:” these concepts may sound like science fiction, but they are being written about in reputable journals. To assess the implications of these emerging prospects for future spaceflight, NASA supported the Breakthrough Propulsion Physics Project from 1996 through 2002. This project has three grand challenges: (1) Discover propulsion that eliminates the...

Breakthrough to Nursing: a past Breakthrough chairperson looks back.