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Comments on the FDA’s Proposal to Change the Approval Package Documentation Posted on the Agency’s Website For New Drugs and Biologics

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Public Citizen strongly objects to the Food and Drug Administration’s (FDA’s) proposal to use and publicly post, upon approval of a new drug applications or biologics license application, an abbreviated integrated review document in place of the more detailed individual medical, chemistry, pharmacology, statistical, clinical pharmacology biopharmaceutics, and risk assessment and risk mitigation reviews, among others, that have been prepared and regularly posted on the FDA website for many years.

See Public Citizen’s other work on the drug approval process.