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FDA announces publication of two proposed rules implementing the Food Safety Modernization Act

USA - January 7 2013 On Friday, January 4, 2013, FDA announced the pre-publication of two long-awaited proposed rules implementing parts of the Food Safety Modernization Act…

Michael D. (Mike) Flanagan

Health care professionals and certificates of medical necessity under FDA consent decrees

USA - April 19 2011 Hospital legal counsel and compliance officers are familiar with the legal ramifications of certifying to medical necessity in the context of Medicare, Medicaid, and other payor reimbursement rules.

Nathaniel M. Lacktman, Heidi A. Sorensen, Lawrence W Vernaglia, Judith A. Waltz

FDA announces plan to improve 510(k) process in 2011

USA - March 24 2011 On January 19, 2011, FDA released its "Plan of Action for Implementation of 510(k) and Science Recommendations."

The FDA warns 17 companies about nutritional claims on food labels and releases U.S. health and diet survey

USA - March 9 2010 March 3, 2010, the FDA announced that it had issued warning letters to 17 food manufacturers, stating that the companies have violated the Food, Drug, and Cosmetic Act (FDCA) by making misleading or unsubstantiated claims on food labels for 22 different products.

Michael D. (Mike) Flanagan, Joyce E. Gresko, David L. Rosen

Biosimilars provision included in House Health Care Reform Bill - the time has finally come

USA - November 2 2009 On October 29, 2009, the Democratic leadership of the House of Representatives released the Affordable Health Care for America Act, H.R. 3962.

Gabor Garai, Stephen B. Maebius, David L. Rosen, Judith A. Waltz