WebMay 3, 2024 · WebApr 5, 2024 · The FDA allows for one pre-IND meeting prior to IND submission to discuss any questions or concerns concerning clinical trial approach. In the process of drug development, a pre-IND meeting is valuable in planning a drug development program, and can provide sponsors information that will assist them in preparing to submit complete …
eCFR :: 21 CFR 312.47 -- Meetings.
WebNov 8, 2024 · According to the FDA guidance, the meeting request for a Type B meeting has to be sent 60 days (for type C 75 days) in advance of the envisaged meeting date. But it very much depends on the availability of the required FDA staff if a meeting date is actually granted within this timeframe. Based on our recent experience CBER granted one Type B ... WebMar 23, 2024 · An IND is often needed for clinical studies with a new drug, a new method of use, new patient population, or in combination w/another approved or investigational product. The pre-IND development phase with the application process can be tedious and lengthy. First time submitters may especially find this time challenging. donna kono md
Pre-IND FDA Meeting Guidance Power
WebCOVID-19 is a perfect example of a novel disease for which there is an urgent need for both vaccines and therapies, with a matching response by many pharmaceutical and biotech organizations that have begun rapid development. To help reduce the application review timelines, the FDA issued guidance regarding Pre-IND meeting requests for COVID-19 ... WebTo submit the meeting request using NMPA application form for consultation meeting. 2. To submit the required consultation meeting package documents. 3. To submit the consultation meeting package within the specific timelines based on the type of meeting. 4. To invite professional people and expert to the meeting based on who WebType C Meetings. Any meeting other than a type A or type B regarding the development and review of a product. A written response to questions posed in pre-IND or Type C meeting requests may be requested by the … donna klimavich