HELP Committee passes five-year reauthorization of FDA drug, medical device and biosimilar user fees with separate provisions expanding agency’s authority to regulate infant formula manufacturing and marketing and establishing Office of Critical Foods in CFSAN.
Senate legislation not only would impose a requirement for infant formula firms to report production disruptions to the US Food and Drug Administration, but also require the agency to expand its regulation of the formula space and establish an office focused on the market.
The agency isn’t telling Capitol Hill yet that a formula shortage across the US has been eliminated, though.
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What's going on with the EU Green Claims Directive? HBW Insight speaks to the European Commission, Parliament and Council to find out why trilogue negotiations seem to have stalled.
Recent warning letters to seven companies marketing products with kratom extract known as 7-OH are FDA’s first in three years referencing unlawful products containing kratom and the first of all its kratom-related warnings to reference extracts from the botanical.
White House announces president extends deadline he set in April for other countries to make new tariff deals from July 9 to Aug. 1, when the administration will start sending letters warning other countries that higher tariffs could take effect.
The agency says items on its Human Foods Program’s proposed agenda for guidance “to complete during 2025” include identity and safety information for NDI notifications. Its announcement also links to document about a separate key industry question, a rulemaking which would recognize NAC as a lawful
A survey asks FDA staff to disclose whether DEI policies caused discrimination or resulted in disciplinary action against career employees over the past five years, but uses a web form that the general public also can access.
White House announces president extends deadline he set in April for other countries to make new tariff deals from July 9 to Aug. 1, when the administration will start sending letters warning other countries that higher tariffs could take effect.
An FDA “expert roundtable” on talc produced a new talking point on a potential drug safety risk, but the basis of that claim is difficult to determine.
