Search Results for 'FDA'

The FDA has issued warning… Read More »

FDA must reconsider imposing the pre-market approval paradigm of food additives to dietary supplements as proposed in its New Dietary Ingredient (NDI) Draft Guidance, according to a commentary by the Council for Responsible Nutrition (CRN), Wa… Read More »

Food and Drug Administration (FDA) must reconsider imposing the pre-market approval paradigm of food additives to dietary supplements as proposed in its… Read More »

In a letter to FDA Commissioner Margaret Hamburg, MD, Senators Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa)—the principal authors of the Dietary Supplement Health and Education Act (DSHEA)—asked Dr. Hamburg to withdraw the agency’s… Read More »

In a letter to FDA Commissioner Margaret Hamburg, MD, Senators Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa)—the principal authors of the Dietary Supplement Health and Education Act (DSHEA)—asked Dr. Hamburg to withdraw the agency's controversial draft guidance on new dietary ingredients (NDI) and begin work on “a new draft that will provide needed clarification on what constitutes an NDI, but does not undermine the balance Congress struck in DSHEA to provide consumers with access to safe, affordable dietary supplement products.” Read More »

FDA has taken legal action against a dietary supplement maker and owner for substituting ingredients and products without noting the changes on the final product labels. The permanent injunction, filed on behalf of FDA by the U.S. Department of Justi… Read More »

Amarin Corporation, Bedminster, NJ, a late-stage biopharmaceutical company focused on cardiovascular disease, has revealed that its New Drug Application (NDA) for AMR101 has been accepted for filing by FDA. The acceptance of the NDA reflects the FDA&… Read More »

The Council for Responsible Nutrition (CRN), Washington, D.C., said it wants FDA to withdraw its New Dietary Ingredient (NDI) Notification Draft Guidance Read More »

The Natural Products Association (NPA), Washington, D.C., has submitted extensive comments to FDA in response to the agency’s draft guidance on New Dietary Ingredients (NDIs). Read More »

FDA has decided to take legal action against a dietary supplement maker and owner for substituting ingredients and products without noting the changes on the final product labels. Read More »

Amarin Corporation, Bedminster, NJ, a late-stage biopharmaceutical company focused on cardiovascular disease, has revealed that its New Drug Application (NDA) for AMR101 has been accepted for filing by FDA. Read More »

FDA has extended the period to submit comments regarding the New Dietary Ingredient (NDI) Notification Guidance by 60 days, to December 2, 2011. Industry groups began calling for an extended comment period shortly after the agency issued its draft gu… Read More »

FDA has grossly underestimated the burden of its New Dietary Ingredient (NDI) notification process on the dietary supplement industry in terms of time resources, according to the Council for Responsible Nutrition (CRN), Washington, D.C., which submit… Read More »