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Medical Device Company Indicted for Off-Label Marketing and Statements Made to FDA During Regulatory Inquiry 19 June 2009 Legal News Alert: Life Sciences Medical device manufacturer Norian Corp. was indicted on June 16, 2009 for, among other things, several false statements the manufacturer’s personnel allegedly made...
FDA Issues Warning Letter to General Mills Objecting to Cheerios® Claims 18 May 2009 Legal News Alert: Food Background The U.S. Food and Drug Administration (FDA) recently issued a Warning Letter to General Mills, Inc. objecting to claims the company makes on its Cheerios®...
President's FY 2010 FDA Budget Proposes Food Industry User Fees 14 May 2009 Legal News Alert: Food Overview President Barack H. Obama’s recently released Fiscal Year (FY) 2010 budget for the U.S. Food and Drug Administration (FDA) proposes historic spending...
Long-Awaited Waxman Biosimilar Bill Introduced With Bipartisan Support But Not Without Challenge — Implications for the Biotech Industry 13 March 2009 Legal News Alert: Life Sciences On March 11, 2009, House Committee on Energy and Commerce Chairman Henry A. Waxman (D-Calif.) and Frank Pallone (D-N.J.), Nathan Deal (R-Ga.), and Jo Ann Emerson...
FDA Requires Identification of Carmine and Cochineal Extract on Food Labels 23 January 2009 Legal News Alert: Food Industry The U.S. Food and Drug Administration (FDA) recently issued a final rule to require the declaration of two color additives — carmine and cochineal extract — on the...
Patenting Risk Evaluation & Mitigation Strategies; For Pharmaceuticals: A New Life Cycle Management Target for Patents? 02 January 2009 BNA's Pharmaceutical Law & Industry Report Foley Partners Stephen Maebius, Judith Waltz, David Rosen and Associate Sean Tu authored an article titled "Patenting Risk Evaluation & Mitigation Strategies;...
Certain Drugs, Cosmetics, and Dietary Supplements Must Comply With New CPSC Certification Requirements 15 October 2008 Legal News Alert: Life Sciences On November 12, 2008, new product conformity certification requirements will go into effect for a wide range of consumer products, including some cosmetics, dietary...
OIG Work Plan Focuses on Quality, DME, and Part D 14 October 2008 Legal News Alert: Health Care The U. S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) began the new fiscal year, as it does each October 1, by issuing its annual...
Newsletter for Leaders in the Medical Device Industry – July 2008 08 July 2008 Legal News: Medical Devices More on the Foreign Corrupt Practices Act and the Medical Device Industry Sharie A. Brown (sbrown@foley.com) In the April 2007 edition of Foley’s Legal News:...