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FDA Advisory Committee Votes to Recommend Keeping Anti-Diabetes Drug Avandia On The Market

GAITHERSBURG, Md. - (Mealey's) A majority of Food and Drug Administration advisers voted July 14 to keep Avandia on the market but split on whether the anti-diabetes drug made by GlaxoSmithKline PLC (GSK) should carry additional warnings about its heart risks or that its use be restricted. Twelve...

Advertising and Food and Drug Law Report: Consent Orders Provoke Debate Over FTC and FDA Substantiation Standards

The advertising community is paying considerable attention to four recent Federal Trade Commission consent orders relating to health claims. For some of those claims, the orders impose a novel requirement under which the U.S. Food and Drug Administration would have to approve the claim for use in labeling...

Employer Compliance Guidance for Whistleblower Provisions Under New Food Safety Modernization Act

As previously reported by Keller and Heckman LLP, President Obama signed the Food Safety Modernization Act (FSMA) into law on January 4, 2011. While most of the provisions regarding stricter food safety standards will not be effective until 2012, FSMA Section 402, which provides sweeping protections...

Foley & Lardner LLP Alert: Federal Agencies Issue New Policy Guidance Documents On The Regulation Of Nanomaterials

In June 2011, several federal agencies issued policy guidance documents regarding the regulation of nanomaterials. Although the guidance documents were issued by several different agencies, including the Office of Management and Budget, the Food and Drug Administration (FDA), and the Environmental Protection...

State Net Capitol Journal Spotlight: Hot Issues Won’t Vary Much in 2014

By Rich Ehisen | For most states, 2013 was a welcome respite from the usual election year political gridlock. That all changes next year, with 38 governorships, 46 legislative chambers, 33 United States Senate seats and all 435 House of Representatives seats up for grabs. But amidst all that politicking...