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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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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…
