Posts from December 5, 2012

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National Influenza Vaccination Week – December 2–8, 2012

From Morbidity and Mortality Weekly Report (MMWR) To highlight the importance of annual influenza vaccination, and to foster greater use of influenza vaccine in the[…]

Improvements in Device Review: Results of CDRH’s Plan of Action for Premarket Review of Devices

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[…]

FDA Guidance Documents Update

Two new draft guidance documents have been posted on the Clinical Trials Guidance Documents page, http://www.fda.gov/RegulatoryInformation/Guidances/ucm240323.htm.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[…]