End of Phase 2 Meeting definition

End of Phase 2 Meeting means the first end of Phase 2 meeting with the FDA, as defined in 21 CFR Section 312.47, intended to determine the safety of proceeding to Phase 3, evaluate the Phase 3 plan and protocols and identify any additional information necessary to support an NDA for Product.
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End of Phase 2 Meeting means a meeting with FDA, the purpose of which is to determine the safety of initiating a first Phase III Clinical Study, to evaluate the Phase III Clinical Study plan and protocols and the adequacy of current studies and plans to assess pediatric safety and effectiveness, and to identify any additional information necessary to support a Drug Approval Application for the uses under investigation, as further defined in 21 C.F.R. 312.47(b)(1), as amended from time to time, or the corresponding foreign equivalent.
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End of Phase 2 Meeting means the end-of-Phase 2 meeting with FDA as described in 21 CFR 312.47(b).
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Examples of End of Phase 2 Meeting in a sentence

  • Larazotide successfully completed the End of Phase 2 Meeting with the FDA to prepare for expected Phase 3 clinical trials for larazotide in celiac disease in late 2017.

  • End of Phase 2 Meeting —in which sponsors seek FDA input on their Phase 3 clinical studies that are generally pivotal to FDA application review and market approval.

  • Based on our discussion with the FDA at our End of Phase 2 Meeting, and the advice we received through the Scientific Advice procedure with the EMA, we have determined the clinical trial design and endpoints for our Phase 3 program.

  • We are pleased to report that at the end of 2018, Neuren stands in an immeasurably stronger position than some 14 months ago prior to our End of Phase 2 Meeting with the US Food and Drug Administration (FDA).

  • Revised exposure numbers are consistent with ICH guidelines.2. Acceptability of 40% elderly enrolled in Phase 3 program (per End of Phase 2 Meeting) will ultimately be a review issue.3. Agreement with the sleep-onset primary endpoint of PSG-determined latency to persistent sleep (LPS; Study 304); substantiated by subjective Sleep Onset Latency (sSOL; Study 303).


More Definitions of End of Phase 2 Meeting

End of Phase 2 Meeting means any “End-of-Phase 2 Meeting” as described in 21 CFR 312.47, or, with respect to the EU, a similar meeting with the EMA.
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End of Phase 2 Meeting means the receipt by Somaxon of the FDA's minutes from the meeting to be held between Somaxon and the FDA to discuss the results of the Phase 2 Clinical Trials.
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End of Phase 2 Meeting means an end-of-phase 2 meeting with the FDA as described in 21 CFR §312.47(b), or the equivalent meeting with the EMA.
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End of Phase 2 Meeting means the end of Phase 2 meeting with the FDA, as described in 21 C.F.R. § 312.47(b), intended to determine the safety of proceeding to Phase 3, to evaluate
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End of Phase 2 Meeting means the first end of Phase 2 meeting with the FDA, as defined in 21 CFR Section 312.47, intended to determine the safety of proceeding to ** CERTAIN INFORMATION (INDICATED BY ASTERISKS) HAS BEEN OMITTED FROM THIS DOCUMENT PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST. AN UNREDACTED VERSION OF THIS DOCUMENT HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION. Phase 3, evaluate the Phase 3 plan and protocols and identify any additional information necessary to support an NDA for Product.
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End of Phase 2 Meeting means any meeting with the FDA for the purpose of (a) reviewing data from a Phase 2 Clinical Trial for a Licensed Product or (b) discussing the design of a pivotal Phase 3 Clinical Trial for a Licensed Product.
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End of Phase 2 Meeting means the end of Phase 2 meeting with the FDA, as described in 21 C.F.R. § 312.47(b), intended to determine the safety of proceeding to Phase 3, to evaluate CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED. the Phase 3 plan and protocols, and to identify any additional information necessary to support a marketing application for the uses under investigation.
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