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Two new draft guidance documents have been posted on the Clinical Trials Guidance Documents page, http://www.fda.gov/RegulatoryInformation/Guidances/ucm240323.htm.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Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed – Draft Guidance…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

A new FDA guidance was announced today in the Federal Register (emphasis added): FDA is announcing the availability of a draft guidance entitled “Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and…