How to make effective comments on the FDA's new "FSMA" regulations *

USA - May 2 2013
As we've previously written, the most sweeping changes to food regulation in decades are underway. To implement the 2011 FDA Food Safety…

Co-authors: Harold K. Gordon, Colleen M. Heisey, June K. Ghezzi.

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Court injunction will require the FDA to accelerate the roll-out of FSMA regulations *

USA - April 25 2013
The Food Safety Modernization Act, known as "FSMA," calls upon the Food and Drug Administration ("FDA") to promulgate extensive new regulations on a…

Co-authors: Robert S. Faxon, Harold K. Gordon, Colleen M. Heisey, June K. Ghezzi, Peter N. Larson .

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The FDA is moving forward on major new "FSMA" regulations *

USA - April 12 2013
In January 2011, President Obama signed the Food Safety Modernization Act. This Act, known as FSMA, directs the FDA to make sweeping changes to how…

Co-authors: Harold K. Gordon, June K. Ghezzi.

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Current trends in the FDA's enforcement of GMP requirements *

USA - March 15 2013
Drugs and devices are "adulterated," as that term is used in the Food, Drug, and Cosmetic Act, if the drugs and devices are contaminated, impure, or…

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European Medicines Agency jeopardizes investments in drug development *

European Union - December 28 2012
The heart of a marketing authorization application ("MAA") is the pre-clinical and clinical data that proves the drug's safety and efficacy. This data is…

Co-authors: Brian J. Forsatz Ph.D. , Mark Kafka , Dr. Christian B. Fulda, Yasunobu Takatama .

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