Clinical Trials Advisor

May 24, 2012 | Vol. 17 No. 11

Device Trials Driven Overseas By Cost, Ease of Patient Recruitment

Device companies will continue to develop products abroad as long as financial and regulatory conditions overseas are more favorable than in the U.S., warned experts at the Food & Drug Law Institute annual meeting in Washington, D.C.

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U.S. FDA Issues Final Guidances on 510(k) Refuse-to-Accept, PMA Review Policies 510(k), PMA Acceptance Guidelines Finalized as of First of Year U.S. FDA Draft Guidance Lays Out Time Clock Strategies for PMAs, 510(k)s FDA Details Time Clock Strategies for PMAs, 510(k)s in Draft Guidance

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