PDUFA Negotiations Focus On Review Delays; Firms, FDA See Different Causes
Industry appears to be showing its strongest hand as PDUFA V negotiations roll along, laying down the cards showing FDA's poor record of meeting user fee goals in recent years
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“JumpStart” analytics service provides data fitness assessments and exploratory safety analyses to clinical reviewers within two weeks following NDA/BLA submission.
NMEs and novel biologics will see reviews allotted two additional months under the revised model launching Oct. 1. Industry expects to gain more communication and first-cycle approvals, while FDA hopes it can receive more complete applications at submission and improve transparency.
High unmet medical need, a genetically targeted patient population and the drug's biological rationale could combine for a faster-than-six-month approval for the novel, disease-modifying therapy.