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ODSP's Welch: NDIN 'guidances are not enforceable'

FDA’s director of the Office of Dietary Supplement Programs (ODSP), Cara Welch, PhD, stopped by SupplySide East to present an overview of the agency’s FY23 activities related to dietary supplements and FY24 plans as well as an update on the pending Human Foods Program reorganization. She sat down with NutraIngredients-USA to discuss these topics and more.
Foods Program Food Program Drug Administration Dietary Ingredient Notification Master Files Dietary Supplements Master Files

FDA Ushers in New Program for Drug Products Manufactured Using Innovative Manufacturing Technologies | King & Spalding

Under Section 3213 of Food and Drug Omnibus Reform Act, the U.S. Food & Drug Administration (“FDA” or the “Agency”) is required to establish the Advanced Manufacturing Technologies...
Ndas Blas King Spalding Technology Team Congress Modernizes Manufacturing Technologies Designation Program Us Food Drug Administration

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All eyes on Dietary Supplement Master Files

Fresh off a new Draft Guidance release, many are hopeful that Master Files would provide clarity on NDI filing requirements and provide protections for intellectual property. However, some point to issues with the NDI framework and say that must be solved first.
Amin Talati Wasserman George Paraskevakos International Food Additives Council International Probiotics Association Health Canada Drug Administration Center

NPA's Fabricant on FDA reorg, HSAs/FSAs, Master Files, NMN and more

From a proposed reorganization of the Food & Drug Administration to progress (or not) on the NMN situation, there’s a lot going on in the dietary supplements industry. We caught up with Daniel Fabricant, PhD, president and CEO of the Natural Products Association, for some updates.
United States Janet Woodcock Bob Durkin Office Of Dietary Supplement Programs Office Of Food Chemical Safety Alliance For Natural Health

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