FDA Issues Approvable Letter For Entereg For POI (Medical News Today)
GlaxoSmithKline (NYSE: GSK) and Adolor Corporation (Nasdaq: ADLR) announced today that the Food and Drug Administration (FDA) has issued a letter stating that the new drug application (NDA) for Entereg (alvimopan 12mg) for the management of post operative ileus (POI) is approvable. [click link for full article]

Device Makers Push for Lower FDA Fees (AP via Yahoo! Finance)
Medical device companies are negotiating with the Food and Drug Administration to pay lower fees for product approval. In closed-door talks, the medical device industry and FDA officials are reviewing the user-fee program in which manufacturers pay the agency when they submit products for approval.

Device industry pushes for lower FDA fees (Sharewatch)
In closed-door talks, the medical device industry and FDA officials are reviewing the user-fee program in which manufacturers pay the agency when they submit products for approval. The goal of the program was to hire additional FDA staffers to help speed up approval times for medical devices.