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FDA Issues Draft Guidance on Use of "Real-World Evidence" in Medical Device Decision-Making

USA - August 4 2016 The U.S. Food and Drug Administration (FDA) issued draft guidance addressing how it may use data and evidence collected outside of the traditional...

Jennifer M. Nowak.

FDA report to Congress: 1997 guidance provides solid foundation for 510(k) modification decisions

USA - March 10 2014 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...

Daniel J. Arking.

Foreign food producers play catch-up as FDA issues draft regulations to implement new food safety standards

USA - July 18 2013 The U.S. Food and Drug Administration (FDA) is in the process of implementing sweeping new regulations governing the production of both domestic and...

Vanessa Patton Sciarra.

FDA holds public meeting in effort to better regulate pharmaceutical compounding

USA - December 26 2012 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...

Shannon Hartsfield Salimone.

FDA moves to regulate advertising of medical procedures by healthcare providers

USA - December 20 2011 Hospitals and physicians might reasonably assume that the Federal Food, Drug and Cosmetic Act (FDCA), administered by the U.S. Food and Drug Administration (FDA), applies to drug and medical device manufacturers and not to them....

Andrew R. Oja, Patrick C. O'Brien.