‘Inaccuracies’ push FDA to reverse Trump-era termination of its Unapproved Drugs Initiative
Due to “multiple legal and factual inaccuracies,” the Biden administration’s FDA said Wednesday that it will reverse the Trump-era decision to pull the agency’s controversial Unapproved Drugs Initiative.
The decision to withdraw the Trump HHS notice terminating the initiative comes as Biden’s FDA says it was never consulted on the decision in the first place, and it does not accurately reflect HHS’ or FDA’s thinking “because it is inconsistent with the FD&C Act, FDA regulations, and judicial precedent, among other legal authorities, and is not supported by the facts,” according to a Federal Register posting on Wednesday.
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