WebApr 5, 2024 · FDA Responses and Meetings for Investigational New Drug Applications Sponsors should review the guidance Formal Meetings with Sponsors and Applicants for PDUFA Products for information on formal meetings with sponsors and applicants. WebJun 23, 2024 · FDA has established different categories of meetings, called Type A, B, and C Meetings. Each meeting type has specific timelines. These meeting types are explained in FDA...
FDA Responses and Meetings for Investigational New Drug …
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What You Need to Know About the New FDA Type D …
WebOct 13, 2024 · Oct 13, 2024, 08:00 ET. FREMONT, Calif. and WALTHAM, Mass., Oct. 13, 2024 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX ), a biopharmaceutical company focused on the discovery, development, and ... WebII. TYPES OF MEETINGS There are three categories of meetings between sponsors or applicants for PDUFA products and CDER or CBER staff: Type A; Type B; and Type C. Each type of meeting will be subject to different procedures, as described below. A. Type A Meeting A Type A meeting is one that is immediately necessary for an otherwise stalled … WebOct 31, 2024 · The Company had a collaborative dialogue with the FDA during the Type A meeting, which was held in order to discuss the key topics in the Complete Response Letter (CRL) issued by the FDA in June 2024. ecker\u0027s flowers waverly iowa