Thursday 24 April 2014

Draft Guidance

FDAUDIrule

FDA Unveils Proposed Device Identification System, New Database

July 3, 2012 | 4 comments

The FDA has released a proposed rule that requires most medical devices distributed in the United States carry a unique […]

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Better Pharmaceuticals and Devices for Children Act

Senators Seek to Improve Safety of Children’s Medications and Medical Devices

April 18, 2012 | No comments

A bipartisan team of Senators announced today new legislation aimed at improving the safety of children’s medications and medical devices. The bill introduced today […]

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womenclinical

FDA Proposes Draft Guidelines to Improve the Representation of Women in Med Device Clinical Studies

December 16, 2011 | No comments

From the FDA: Draft guidance aimed to address the historic underrepresentation of women in clinical studies was issued by the […]

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