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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 unnamed pharma compan | 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 unnamed pharma company in April.
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fiercepharma.com
‘Seeing the evolution’: As branded patent cliff looms, biosimilar experts size up US hurdles, opportunities ahead
The tables have turned for the U.S. biosimilars market. | With more than a decade passed since the first FDA biosim approval, strong launches of biologic copies to AbbVie’s…
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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.
