On February 25, 2013, the U.S. Food and Drug Administration (FDA) released a proposed rule entitled Human Subject Protection: Acceptance of Data From Clinical Studies for Medical Devices. The proposed rule would require that...more
The Chinese State Food and Drug Administration (“SFDA”) announced a plan for regulatory reform (“Reform Plan”) and is soliciting public comments through January 15, 2013. The Reform Plan sets forth the following key strategic...more
The Food and Drug Administration (FDA) recently issued a guidance document related to the conduct of clinical trials to support approval of human drugs and biological products “Draft Guidance for Industry: Enrichment...more
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