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Guidance

FDA Guides on General Wellness and Low Risk Devices

On January 20, 2015, the U.S. Food and Drug Administration (FDA) published a proposed guidance document regarding the FDA’s current…

FDA Publishes Food Allergen Labeling Guidelines

On May 8, 2014, the U.S. Food and Drug Administration (FDA) published its "Draft Guidance for Industry: Food Allergen Labeling…

FDA Publishes Draft Guidance on Honey Labeling

On April 11, 2014, the U.S. Food and Drug Administration (“FDA”) published a draft guidance document, entitled “Draft Guidance for…

FDA’s CFSAN Announces Plan for Program Priorities

On September 4, 2013, the Center for Food Safety and Applied Nutrition (CFSAN or the Center), a public health regulatory…

FDA Updates Draft Guidance on Medical Foods

On August 13, 2013, the U.S. Food and Drug Administration (FDA) published its “Draft Guidance for Industry: Frequently Asked Questions…

FDA Warns Online Cigarette Retailers for Marketing Violations

In January 2013, the U.S. Food and Drug Administration (”FDA”) sent out several warning letters to online retailers of cigarettes,…

FDA Publishes Final Guidance Explaining Egg Safety Rule

On August 20, 2012, the U.S. Food and Drug Administration (“FDA”) announced the availability of the final guidance document entitled…

FDA Releases Draft Guidance Updating Warnings for Labeling of Albumin, Highlighting Risk of Creutzfeldt Jakob Disease

On June 11, 2012, the U.S. Food and Drug Administration (“FDA”) published a draft guidance document, entitled Draft Guidance for…