The FDA approved 35 new drugs in the fiscal year ending Sept. 30 (FY2012), the same number of drugs that were approved in FY2011, according to a recent report. About 77% of the approvals were completed in a single review…

In January 2011, the FDA announced a Plan of Action to modernize and improve the FDA’s premarket review of medical devices. In the two years since FDA began implementing the plan, the speed and predictability of device review have improved…

Two new draft guidance documents have been posted on the Clinical Trials Guidance Documents page, http://www.fda.gov/RegulatoryInformation/Guidances/ucm240323.htm. IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed – Draft Guidance…

From USDA: WASHINGTON, Dec. 3, 2012 – The U.S. Department of Agriculture’s (USDA) National Institute of Food and Agriculture (NIFA) today announced nearly $17 million in grants to tribal colleges and universities to support research, education and extension activities to…

FDA is proposing to tighten up exemptions for custom devices under 21 CFR 812.520(b). According to the FDA Law Blog: As amended, section 520(b) will exempt devices from the requirements of section 514 or 515 if the device: Is “created or…