WebPrior to the meeting with the FDA, the Pre-Phase 3 Briefing Package provided an up-to-date summary of the extensive work completed for the XRx-008 program, including updates regarding chemistry, manufacturing, pharmacology, toxicology, clinical results to date, and regulatory and clinical plans. ... Pre-investigational new drug application (pre ... WebMay 12, 2024 · The pre-IND meeting is usually a drug sponsor’s first formal meeting with the FDA as they begin the process of bringing a drug to market. The meeting provides sponsors the opportunity to discuss their IND plans prior to the full IND submission. This interaction is where the drug sponsor can receive insight into the FDA’s current thinking.
A GUIDE TO FDA MEETINGS - PharmaLex
WebDec 16, 2024 · The goal of the Pre-IND Conference is to receive confirmation from the FDA that drug development plans and future clinical trials will be accepted by the FDA. Therefore, it is important for sponsors to remember that they need full transparency to get the most value out of their meetings. Using Pre-IND Meeting in the right way can help … WebMar 6, 2024 · A new draft guidance from FDA explains how sponsors can submit a formal request for a meeting, which can be face-to-face, teleconference/ videoconference meetings or written responses only, what sponsors should include in that request, how FDA can respond, how long the agency can take to respond, and how the sponsor and FDA can … hatch consultora
IND Templates, Education and Useful Links ResearchGo UCLA
Web6 rows · Jun 23, 2024 · The meeting package for a pre-IND should be submitted no later than 30 days before the ... http://www.ehcca.com/presentations/fdasymposium2/colangelo.pdf WebMay 28, 2015 · Where data. 9. 1.6 Meetings 1.6.2 Pre-IND Meeting Background Materials Page 9 of 13 presentation is appropriate, sponsors should present a summary of the data (e.g., tables, charts, graphs). The pre-IND meeting should focus on the specific questions related to the planned clinical trials. The meeting should also include a discussion of … hatch consultancy asbestos