I may be wrong but I wonder if (upon reading the 2
Post# of 72447
(Total Views: 385)
Posted On: 11/02/2018 12:43:53 PM
I may be wrong but I wonder if (upon reading the 2nd sentence in the 1st paragraph on this site and the 2nd sentence of the 2nd paragraph)IPIX would need to know if they got BTD in order to prepare this briefing package for the EOP2 meeting??
Kelt
http://www.regardd.org/drugs/drug-development/meetings
End-of-Phase 2 Meeting
An end-of-Phase 2 meeting (EOP2) is a formal meeting between the sponsor of an IND, the regulatory contact, and the FDA. The purpose of an EOP2 meeting is to determine the pathway for proceeding to a Phase 3 study, to evaluate the Phase 3 plan and protocol for adequacy, to assess pediatric safety and effectiveness, and to identify any additional information that would be needed to support a marketing application. This provides the sponsor an opportunity to get FDA input prior to conducting an expensive Phase 3 study.
The FDA will schedule the EOP2 meeting within 60 days of receiving the written meeting request. At least 30 days prior to the EOP2 meeting, the sponsor should submit a meeting package containing the plan for Phase 3, summaries of Phase 1 and 2 investigations, specific protocols for Phase 3 studies, plans for pediatric studies, and tentative labeling for the drug, if available. The initial meeting request and the meeting package should contain a proposed agenda and a list of questions. Any agreements reached during the meeting will be recorded in the FDA meeting minutes and provided to the sponsor. Studies conducted in accordance with the agreement will be presumed to be sufficient in objective and design for the purpose of obtaining marketing approval of the drug.
Kelt
http://www.regardd.org/drugs/drug-development/meetings
End-of-Phase 2 Meeting
An end-of-Phase 2 meeting (EOP2) is a formal meeting between the sponsor of an IND, the regulatory contact, and the FDA. The purpose of an EOP2 meeting is to determine the pathway for proceeding to a Phase 3 study, to evaluate the Phase 3 plan and protocol for adequacy, to assess pediatric safety and effectiveness, and to identify any additional information that would be needed to support a marketing application. This provides the sponsor an opportunity to get FDA input prior to conducting an expensive Phase 3 study.
The FDA will schedule the EOP2 meeting within 60 days of receiving the written meeting request. At least 30 days prior to the EOP2 meeting, the sponsor should submit a meeting package containing the plan for Phase 3, summaries of Phase 1 and 2 investigations, specific protocols for Phase 3 studies, plans for pediatric studies, and tentative labeling for the drug, if available. The initial meeting request and the meeting package should contain a proposed agenda and a list of questions. Any agreements reached during the meeting will be recorded in the FDA meeting minutes and provided to the sponsor. Studies conducted in accordance with the agreement will be presumed to be sufficient in objective and design for the purpose of obtaining marketing approval of the drug.
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