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FDA Issues Draft Guidance on Use of "Real-World Evidence" in Medical Device Decision-Making

The U.S. Food and Drug Administration (FDA) issued on July 27, 2016, a draft guidance document addressing how it may use data and evidence collected outside of the traditional clinical trial context to support medical device...more

FDA Report to Congress: 1997 Guidance Provides Solid Foundation for 510(k) Modification Decisions

Interested stakeholders have until June 4, 2014, to comment on the FDA's long-anticipated report to Congress that includes its Proposed Policy on the Premarket Notification Requirements for Modified Medical Devices. The FDA...more

3/11/2014  /  FDA , FDASIA , Medical Devices

Foreign Food Producers Play Catch-Up as FDA Issues Draft Regulations to Implement New Food Safety Standards

The U.S. Food and Drug Administration (FDA) is in the process of implementing sweeping new regulations governing the production of both domestic and imported food products. Many foreign food producers will be at a...more

FDA Holds Public Meeting in Effort to Better Regulate Pharmaceutical Compounding

On December 19, 2012, the U.S. Food and Drug Administration (FDA) held a public meeting, broadcast live on the Internet, to discuss the respective roles of the federal and state governments in regulating pharmacy compounding....more

12/27/2012  /  Drug Compounding , FDA , Pharmacies
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