FDA Issues New Draft Guidance on Submitting Formal Meeting Requests

A new draft guidance from FDA explains how sponsors can submit a formal request for a meeting, which can be face-to-face, teleconference/videoconference meetings or written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 go about conducting efficient, consistent, timely and effective meetings. Meeting Types FDA describes four types of meetings. Type A meetings are those that are necessary for an otherwise stalled product development program to proceed or to address an important safety issue. Before submitting a Type A meeting request, requesters should contact the review division or office to discuss the appropriateness of the request. Type B meetings include, but are not limited to: Pre-investigational new drug application (pre-IND) meetings; Pre-emergency use authorization meetings; and Pre-new drug application (pre-NDA)/pre-biologics license application (pre-BLA) meetings (21 CFR 312.47). Type B (EOP) meetings are as follows: Certain end-of-phase 1 meetings (i.e., for products that will be considered for marketing approval under 21 CFR part 312, subpart E, or 21 CFR part 314, subpart H, or similar products) and end-of-phase 2 or pre-phase 3 meetings (21 CFR 312.47). A Type C meeting is any meeting other than a Type A, Type B, or Type B (EOP) meeting regarding the development and review of a product, including meetings to facilitate early consultations on the use...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs