‘FASTER’ Path For US FDA To Identify Allergens, Impose Related Rules Passes House Committee
“Food Allergy Safety, Treatment, Education, and Research Act of 2019” would amend FDA regulations to include sesame as major allergen and allow agency to add other ingredients as major allergens based on prevalence and severity of allergic reactions. Separately, FDA FY2021 budget part of minibus set for House vote week of 20 July.
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Appropriators’ FDA FY 2021 budget includes amendment to expand its mandatory recall authority introduced by chairman of subcommittee with oversight of agency’s budget, Rep. Sanford Bishop. He said the agency should be able to force drug product recalls as it already can for vaccines, medical devices and products containing ingredients also scheduled as controlled substances.
Approval of Alaway Preservative Free (ketotifen fumarate, 0.035) comes 15 months after FDA submitted a complete response letter to Bausch and the active ingredient developer, Eton Pharmaceuticals.
Unfounded expectation some firms have for FDA to protect their investments in preparing successful NDI notifications is part of industry’s overall interest in increased regulation of the market, says Steven Tave, Office of Dietary Supplement Programs director.