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Major FDA reorganization will heavily impact human foods program - LexBlog
What started as a crisis over the safety and supply of infant formula became a wide-ranging review of FDA’s food programs by the Reagan-Udall Foundation.
Qualifying Biomarkers to Support Rare Disease Regulatory Pathways
Qualifying Biomarkers to Support Rare Disease Regulatory Pathways
Case example: Heparan sulfate in neuronopathic lysosomal storage diseases
Public Workshop: In-Person and Virtual
February 21, 2024 | 10am-4pm (eastern)
FDA’s Center for Tobacco Products Publishes Strategic Plan - JD Supra
The Food and Drug Administration’s Center for Tobacco Products (“CTP”) has released a strategic plan intended to guide the Center’s activity for the next five years. While the strategic plan highlights the laudable goals of regulatory clarity, stronger enforcement against non-compliant actors and more timely and transparent application review, the plan is problematic in that it promotes an agenda of burdensome new regulations and does not provide a clear emphasis on the promotion of less harmful alternatives in the tobacco and nicotine marketplace.