Spiration, Inc. Receives First FDA Approval for Bronchial Valve (Centre Daily Times)
Spiration, Inc., a developer of novel medical devices designed to benefit patients with acute and chronic conditions of the lung, announced today that the company has received Humanitarian Device Exemption (HDE) approval from the U.S. Food and Drug Administration (FDA) for the use of its minimally invasive IBV(R) Valve System to control prolonged air leaks of the lung, or significant air leaks ...

The FDA Approves Production Process Strategy Of Aplidin(R), New Marine-Derived Anti-Tumor Agent, Proposed By PharmaMar (Medical News Today)
The Food and Drug Administration (FDA) has accepted the proposal made by PharmaMar, of the Zeltia Group for the production process of Aplidin , a new marine-derived anti-tumor agent, in clinical development for the treatment of hematological and solid tumors. The starting materials for the initiation of the production process have also been approved.

FDA should lift stevia import alert, says ABC (Nutraingredients.com)
In the upcoming issue of HerbalGram , ABC s publication, Mark Blumenthal, ABC s founder and executive director, calls FDA s 1991 Import Alert on stevia for use as a food additive "unreasonable and illogical" given the "current scientific and medical information supporting the safety of stevia when consumed in relatively small amounts in foods to give them a sweet taste."