Acusphere Receives Complete Response from FDA (Centre Daily Times)
Acusphere, Inc. announced today that it has received a complete response from the U.S. Food & Drug Administration (FDA). The response was largely consistent with the feedback received at the Advisory Committee meeting on December 10, 2008, and discussions that continued with FDA in January 2009. In general, their response suggested that additional clinical work would be required to support the ...

FDA Shuts Down A Flour Tortilla Manufacturer For Repeated Violations - Failure To Correct Drove Action (Medical News Today)
The U.S. Food and Drug Administration (FDA) announced that Del Rey Tortilleria Inc., Chicago, Ill., its president, and two general managers have entered into a consent decree of permanent injunction that prevents Del Rey Tortilleria from manufacturing and distributing soft-shell flour tortillas until the company obtains FDA approval.

Clarification on Regulatory Decisions on Antipsychotic Trials Brought During ISCTM Annual Meeting (Business Wire via Yahoo! Finance)
WASHINGTON----A half-day symposium on emerging regulatory practice around approvals for antipsychotic compounds was held March 4, 2009, at the Annual Meeting of the International Society for CNS Clinical Trials and Methodology in Arlington, VA.