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Recent FDA Enforcement Letters Lay Out Roadmap for Future Scrutiny of Efficacy Claims

USA - October 23 2018 The U.S. Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) recently released the third untitled letter in 2018 to...

Coleen Klasmeier, Torrey Cope.


U.S. Department of Agriculture's Proposed National Bioengineered Food Disclosure Standard Raises More Questions Than It Answers

USA - May 9 2018 On May 3, 2018, the U.S. Department of Agriculture (USDA) Agricultural Marketing Service (AMS) published its long-awaited proposed rule implementing...

Emily Marden, Deepti A. Kulkarni, Diane C. McEnroe.


FDA Announces Plans for Three Public Meetings and a Pilot Project Program Under the Drug Supply Chain Security Act

USA - July 27 2017 On July 20, 2017, the Food and Drug Administration (FDA) published a notice announcing three public meetings entitled "Enhanced Drug Distribution...

William A. McConagha, Diane C. McEnroe.