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FDA quietly stops releasing CRLs
FDA paused public release of pharma rejection letters (CRLs) after a law firm's April citizen petition. Last published CRL was for AbbVie's botox shot on April 22.
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endpoints.news
HHS lays groundwork for new FDA rule on releasing the CRLs
Trump administration pushes the FDA to formalize its release of drug rejection letters via new rulemaking, with DTC ad and Phase 1 rules also on the agenda.
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fiercebiotech.com
FDA halts release of new drug rejection letters while working to formalize policy
The FDA has paused a controversial policy of releasing letters describing its rationale for rejecting drugs, Fierce Biotech has learned, following a citizen’s petition from an…
