POM Wonderful opinion provides limited clarification on FTC substantiation requirements *

USA - October 1 2012
The food and dietary supplement industries have struggled to interpret and implement the Federal Trade Commission’s (FTC’s) unsettled standard on health claim substantiation.

Co-authors: Patrick C. English, Carolyne R. Hathaway.

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The Food and Drug Administration Safety and Innovation Act of 2012: assessing the impact on the medical device industry *

USA - July 17 2012
On July 9, 2012, President Obama signed the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) into law.

Co-authors: Amy Gaither, John R. Manthei.

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The Food and Drug Administration Safety and Innovation Act of 2012: assessing the impact on the pharmaceutical and biotechnology industries *

USA - July 16 2012
On July 9, 2012, President Obama signed the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) into law.

Co-authors: Amy Gaither, John R. Manthei.

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An ounce of prevention: FDA issues first rules under FSMA intended to prevent unsafe food from entering the market *

USA - June 3 2011
Recent, high profile recalls of contaminated food products have highlighted the difficulty of responding to a food safety concern after the products have made their way to consumers.

Co-authors: J. Benneville (Ben) Haas, Carolyne R. Hathaway.

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FDA announces actions designed to improve the 510(k) premarket clearance process *

USA - January 27 2011
On Wednesday, January 19, 2011, the FDA released a plan to improve the current 510(k) program by announcing 25 action items "it intends to implement during 2011 to improve the most common path to market for medical devices."

Co-authors: John R. Manthei, J. Benneville (Ben) Haas.

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