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FDA Deputy Commissioner Details Agency’s Priorities In Recent Speech

In This Issue: - Snapshot of the Agency: FDA-regulated products - Recent Public Health Milestones - Innovative Programs at FDA ..A. FDA has a number of programs intended to speed the availability of...more

CMS Proposes New Standards and Processes for Medicare Coverage of Investigational Devices and Related Clinical Studies and Trials

In its proposed update to the Physician Fee Schedule for calendar year 2014, the Centers for Medicare & Medicaid Services (CMS) suggested major revisions to its regulations governing Medicare coverage of investigational...more

Industry Reacts to FDA Proposed Revisions to Acceptance of Data From Clinical Studies for Medical Devices

On February 25, 2013, the Food And Drug Administration (FDA) issued proposed rules to amend its regulations on acceptance of data from clinical studies in support of medical device applications. The FDA noted that current...more

Medical Device Industry Responds to FDA's Overseas Clinical Trial Proposed Rule

In a resounding manner, members of the medical device industry recently filed comments reacting to the Food and Drug Administration’s proposed rule to strengthen its oversight of overseas clinical studies of medical devices....more

Clinical Trials And Corruption Risks

Pharmaceutical and medical device companies have enough to worry about when it comes to enforcement risks....more

FDA Issues Proposed Rule Amending Regulations Regarding Acceptance of Data from Clinical Studies for Medical Devices

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

FDA Issues Draft Guidance for Clinical Trials Using Enrichment Strategies

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guidance document related to the conduct of clinical trials to support approval of human drugs and biological products “Draft Guidance for Industry: Enrichment...more

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