FDA’s ‘Imminent Action’ Policy Likely Not Best Path For ANDAs To Address Late Brand Label Changes
The policy allowing the FDA to work past a goal date could be used to deal with the generic delaying tactic, but an industry expert said other avenues to quickly dispatch labeling issues may be more appropriate.
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Sen. Richard Burr introduces a reauthorization bill without any policy changes, even ones he previously endorsed, saying it’s the clearest path forward now.
US FDA/Industry Thinking PDUFA VIII Could Be A Hybrid Negotiation
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Holding ANDA Labeling Review Until Late Cycle Could Minimize Delays From Last-Minute Changes
A GDUFA III adjustment could allow more labeling changes during the review cycle and reduce assessment cycles.