US Infant Formula Supply Chain Strategy Delivered
FDA immediate actions include ensuring providers know they’re required to develop redundancy risk management plans, enhancing inspections of manufacturers, including by expanding and improving training for investigators, and expediting reviews of premarket submissions for new products.
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In Food Programs Restructuring, US FDA Has Designs On Clear Priorities, Chain Of Command
Following reviews prompted largely by formula supply crisis, FDA will move Center for Food Safety and Applied Nutrition and commissioner’s Office of Food Programs and Response to Human Foods Program headed by deputy commissioner. Office of Regulatory Affairs' structure also changing “to support the FDA organization as a whole,” says Commissioner Califf.
Congress Boosts FDA Food Safety Budget Nearly $700M, Orders Reports On Formula Supply
Appropriators are “concerned by the fragility of the infant formula supply chain and the detrimental health impacts that can arise from shortage of these regulated products.” Their report published with FY2023 omnibus appropriations also asks for list of Russian firms with pending NDAs, including OTCs.
US FDA Turns To Temporary Enforcement Discretion For Boosting Infant Formula Supply
FDA launches temporary enforcement discretion on infant formula product to help increase supply in US on same day consent decree announced to allow Abbott to restart production at facility closed since February, prompting ongoing formula shortage.