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Formal Meetings Between the FDA and Sponsors or Applicants of …

WebPRE-IND BRIEFING PACKAGE. If the FDA meeting is granted, sponsors must provide a pre-IND meeting briefing package to the Division of Transplant and Ophthalmology Products … WebMay 10, 2016 · It’s 100% possible to file pre-NDA meeting requests, meeting packages and meeting minutes via eCTD in advance of the original NDA submission. The first step in the process is asking the FDA to assign an application number. It’s a straightforward process that only requires an exchange of emails. Typically sponsors hear back in less than a week. pin code of kutch

Pre-Clinical Research, Design & Planning - ProPharma

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