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Latest From Acrotech Biopharma LLC

BeiGene’s Tevimbra And The End Of The COVID Inspection Era

US FDA approves the PD-1 inhibitor 20 months after user fee goal, resolving one of the last applications delayed by China’s extended pandemic travel restrictions.

US FDA Performance Tracker Approvals

Pazdur On Accelerated Approval: FDA Needs To Explain Why It Does Not Always Seek Withdrawal When Trials Fail

Knee-jerk reaction when a confirmatory trial fails is that the drug should be withdrawn, but the agency must undertake a more nuanced evaluation and do a better job explaining it to the public, OCE Director Richard Pazdur says; Pazdur and Project Confirm lead Gautam Mehta spoke with the Pink Sheet about dangling indications, FDORA reforms and the withdrawal process.

Review Pathway Post Market Regulation & Studies

Confirmatory Trials: Flexibility In Timing Hinges On Accelerated Approval Indication Size – FDA’s Marks

CBER director suggests more flexibility on confirmatory study timing is warranted for accelerated approvals in rare diseases and even in some more common scenarios such as infectious disease outbreaks, although a ‘relatively stronger approach’ will apply to most large indications.

Review Pathway Post Market Regulation & Studies

FDORA Effect? For Accelerated Approval Class Of 2023, Most Confirmatory Trials At Least Underway

Of 11 NMEs and novel biologics, only one – a vaccine for a tropical disease – did not have confirmatory studies underway or completed at the time of accelerated approval. Statutory changes are forcing companies to prioritize confirmatory trials earlier than in the past.

Pink Sheet Perspectives Review Pathway
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