FDA’s 2021 Budget Priorities For Cosmetics, Food Programs Include AI Use In Postmarket Oversight
FDA’s food, dietary supplement and cosmetics division seeks funding to support its artificial intelligence capabilities, including post-market surveillance and speedy interventions in instances where safety issues arise. Also of note, the agency cites UV filters’ effects on the skin microbiome as a research priority in its fiscal 2021 budget justification to Congress.
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In addition proposing $28.4m in monograph user fees, agency’s FY 2021 budget justification includes among its legislative initiatives proposing to require "Field Alert Reports" for drug products not marketed under an approved application, such as monograph OTCs.
FDA includes cannabis product regulation in FY 2021 food safety priorities, “key areas where resources have been historically underfunded and for which there are rising public health needs as growing markets outpace increases to Agency resources,” it states in its budget request.
FDA proposed final sunscreen monograph identifies zinc oxide and titanium dioxide as GRASE, two other ingredients as non-GRASE and 12 substances with data gaps, meaning firms must provide safety and effectiveness data or reformulate products that rely on inadequately supported UV filters. EWG says the proposal is “exactly the kind of signal that FDA should be providing for the sunscreen industry.”