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FDA to Host Public Workshop on Mobile Medical Apps Guidance
The FDA announced that it will host a public workshop on September 12th and 13th, 2011 to gather input on the agency’s recently issued draft guidance document, “ Mobile Medical Applications .” The FDA issued the…
Supreme Court Rules on Generic Drug Labeling Preemption
On June 23, 2011, the Supreme Court rendered its decision in Pliva, Inc. v. Mensing holding that FDA regulations governing generic drug products directly conflict with and preempt state laws that would require generic…
What You Need to Know About the Law Relating to the Marketing of Dietary Supplements in the U.S., the EU and China
Consumers around the world are increasing their use of dietary supplements. In the United States alone, consumers spend almost $27 billion per year on dietary supplements, and the EU and China are also rapidly…
Non-Profit Sues 34 Sellers of "Organic" Cosmetics
Last week, the Center for Environmental Health, a non-profit organization, filed a complaint in California Superior Court alleging that 34 cosmetics companies violated the California Organic Products Act of 2003…
Sens. Hatch and Harkin Send Letter to FDA in Anticipation of NDI Guidance
Senators Hatch and Harkin, the principle architects of the Dietary Supplements Health and Education Act (DSHEA) (amending the Federal Food Drug and Cosmetic Act (FDCA)), submitted a letter yesterday to FDA Commissioner…