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FDA Issues New Draft Guidance on “Least Burdensome” Principles for Medical Devices

USA - December 21 2017 On December 15, the U.S. Food & Drug Administration (FDA) issued “The Least Burdensome Provisions: Concept and Principles: Draft Guidance for Industry...

Chanda A. Miller.


FDA Grants One-Year Extension on Intended Use Rule

USA - March 23 2017 The Food and Drug Administration (FDA) has announced a one-year extension of a rule related to what pharmaceutical and device manufacturers can say...

Daniel A. Dorfman.


Final FDA guidance clarifies “Dear Doctor” letter requirements

USA - February 10 2014 On January 23, 2014, the United States Food and Drug Administration ("FDA") released a final guidance entitled Dear Health Care Provider Letters:...

Zoha Barkeshli.


FTC expands patent transfer rights reporting rules, effective December 16, 2013

USA - December 16 2013 On November 6, 2013, the Federal Trade Commission released final amendments to the Hart-Scott-Rodino Premerger Notification Rules to clarify when a...

Julie L. Tersigni.


FTC amendments to Premerger Notification Rules: the who, what & why

USA - December 16 2013 On November 6, 2013, the Federal Trade Commission released final amendments to the Hart-Scott-Rodino Premerger Notification Rules to clarify when a...

Julie L. Tersigni.