Accelerated Regulatory Approval definition
Accelerated Regulatory Approval means a Regulatory Approval by the FDA pursuant to 21 C.F.R. Subpart H, “Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses,” as set forth in 21 C.F.R. §500 et al.
Accelerated Regulatory Approval means (i) an accelerated approval of an indication by the FDA based on a surrogate or an intermediate clinical endpoint under Section 901 of the Food and Drug Administration Safety Innovations Act (FDASIA), and (ii) that the prescribing label states “that the drug was approved based upon accelerated approval and that continued approval for the drug (or indication) may be contingent upon verification and description of clinical benefit in a confirmatory trial or trials.”
Examples of Accelerated Regulatory Approval in a sentence
If Subsequent Regulatory Approval is obtained, Nektar’s obligation to make Success Payments shall resume and the due date for payments pursuant to Section 6.1.1 or 6.1.2, as applicable, following such Subsequent Regulatory Approval shall be extended by the number of days between the withdrawal of the Accelerated Regulatory Approval and the applicable Subsequent Regulatory Approval.