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Another One Bites the Dust: FDA doesn’t like the fishy smell of the latest court decision on off-label dissemination

USA - August 19 2015 The Food and Drug Administration has lost yet another court decision challenging its ability to restrict a company's commercial free speech rights…

Alan G. Minsk

Georgia Senator introduces the Combination Product Regulatory Fairness Act of 2015

USA - July 21 2015 On July 17, 2015, Georgia's U.S. Senator Johnny Isakson (R-GA), along with co-sponsors, Robert Casey (D-PA), and Pat Roberts (R-KS), introduced a…

FDA issues ban on artificial trans fat in processed foods

USA - June 23 2015 On June 15, 2015, the U.S. Food and Drug Administration announced a final determination order regarding the use of partially hydrogenated oils (PHOs)…

Alan G. Minsk

Expanded access to unapproved drugs recast: FDA simplifies compassionate use application process

USA - February 17 2015 On February 10, 2014, the Food and Drug Administration (FDA) announced in the Federal Register the release of a new draft guidance that makes changes…

Key FDA guidance documents for section 503B outsourcing facilities

USA - December 17 2014 In late November, 2014, the Food and Drug Administration (FDA) released two final guidance documents and one revised draft guidance relating to drug…