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1 - 15 of 445 results
Published January 5, 2012
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 Hamburg to withdraw the agency's controversial draft guidance on new dietary ingredients (NDI) and begin work on “a new draft that will provide needed clarification on what constitutes an NDI, but does not undermine the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 »
By Todd Harrison & Paul Feinstein
Published January 2, 2012
Revisions to the notification guidance must be more reasonable and less restrictive. Read More »
Published January 2, 2012
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 »
Published December 2, 2011
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 »
Published December 2, 2011
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Nutrition (CRN), Washington, D.C., said it wants FDA to withdraw its New Dietary Ingredient (NDI) Notification Draft Guidance Read More »
Published December 1, 2011
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Products Association (NPA), Washington, D.C., has submitted extensive comments to FDA in response to the agency’s draft guidance on New Dietary Ingredients (NDIs).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 »
Published November 29, 2011
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 »
Published November 28, 2011
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 »
Published October 3, 2011
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 »
Published October 3, 2011
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 »
Published September 20, 2011
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 submitted comments to the Office of Management and Budget. Read More »
Published September 8, 2011
Sabinsa Corporation, East Windsor, NJ, has received confirmation that five of its SAMI Labs in India (the company’s manufacturing center) recently underwent FDA inspection. FDA found no issues of concern in four of the facilities inspected. The… Read More »
Published September 8, 2011
FDA has extended the period to submit comments regarding the New Dietary Ingredient Notification Guidance by 60 days, to December 2, 2011.
Industry groups began calling for an extended comment period shortly after the agency issued… Read More »
By Todd Harrison
Published September 1, 2011
Discussing the highlights of the new guidance and what it means for the supplement business. Read More »
Published September 1, 2011
Trade associations respond, requesting an extended comment period. Read More »
