• where experts go to learn about FDA
  • Month: June 2013

    • The Medical Device Amendments of 1976: The Statute That Went AwryJune 3rd, 2013

      By Jeffrey K. Shapiro – The Medical Device Amendments  of 1976 (“MDA”), Pub. L. No. 94-295, 90 Stat. 539 (1976), are commonly described as the beginning of the modern era of device regulation.  In one sense, this description is absolutely correct.  The MDA established for …

    • 2015 Dietary Guidelines Deliberations Get UnderwayJune 3rd, 2013

      By Ricardo Carvajal – DHHS and USDA announced the inaugural meeting of the 2015 Dietary Guidelines Advisory Committee (DGAC), scheduled for June 13-14.  At the inaugural meeting, the DGAC will be provided with an orientation to the process for revising the Dietary Guidelines (revisions take place …