Type C meetings are basically a “catch all” category and includes any meeting concerning the development and review of a product that does not fall within the scope of Types A or B. The FDA notes that it will attempt to schedule all Type C meetings within 75 days of receiving the written meeting request.
Table of Contents
What are Type C meetings?
Type C meetings are basically a “catch all” category and includes any meeting concerning the development and review of a product that does not fall within the scope of Types A or B. The FDA notes that it will attempt to schedule all Type C meetings within 75 days of receiving the written meeting request.
What is Type B meeting?
Type B meetings, which are routine meetings occurring at pre-defined endpoints between FDA and a sponsor. Meetings typically occur right after or right before the submission of clinical data or a new drug filing.
What is a pre BLA meeting?
Pre-BLA Meeting means a meeting with FDA, the primary purpose of which is to uncover any major unresolved problems, to identify those studies that the sponsor is relying on as adequate and well-controlled to establish the drug’s effectiveness, to identify the status of ongoing or needed studies adequate to assess …
How do I prepare for an FDA meeting?
Outline and rehearse contingency plans. Consider the need for a formal presentation. Critically evaluate preliminary feedback from the FDA and the implications for your program. Prepare follow-up discussion points, questions, and “fallback positions” on key questions at the meeting.
What is end-of-Phase 2 meeting?
The purpose of an end-of-phase 2 meeting is to determine the safety of proceeding to Phase 3, to evaluate the Phase 3 plan and protocols and the adequacy of current studies and plans to assess pediatric safety and effectiveness, and to identify any additional information necessary to support a marketing application for …
What is an FDA briefing book?
Abstract. Health authority briefing documents (also known as briefing packs, briefing packages, and briefing books) are documents prepared by a pharmaceutical company to support its interactions (e.g. pre-submission meetings, requests for scientific advice, and protocol assistance) with health authorities.
What is Type A meeting?
Type A Meeting – is a meeting that is “immediately necessary for an otherwise stalled drug development program to proceed.” This type of meeting refers to meetings to resolve disputes, talk about clinical holds, special protocols. Think of them as a “Type A Personality” meetings.
Is pre NDA meeting required?
Although a Pre-NDA Meeting is not a requirement, we would not recommend submitting an NDA without first meeting with the Agency. Drug development rarely goes exactly as planned, and keeping communication open with the Agency increases your chances of achieving success the first time around.
What is an FDA briefing document?
The attached package contains background information prepared by the Food and Drug Administration (FDA) for the panel members of the Advisory Committee. The FDA background package often contains assessments and/or conclusions and recommendations written by individual FDA reviewers.
What is NDA and IND?
The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.
What is the purpose of the Phase 3 meeting?
The meeting should be directed primarily at establishing agreement between FDA and the sponsor of the overall plan for Phase 3 and the objectives and design of particular studies. The adequacy of the technical information to support Phase 3 studies and/or a marketing application may also be discussed.
What is an end of phase 1 meeting?
End-of-Phase 1 (EOP-1) Meeting: When data from phase 1 clinical testing are available, the sponsor may again request a meeting with FDA-reviewing officials.
What is a Type C meeting?
Type 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 sponsor FDA may determine that a written response would be the most appropriate means for responding to a meeting request
What is a Type C meeting with the FDA?
A Type C meeting is any meeting other than a Type A or Type B meeting between CBER or . CDER and a sponsor or applicant regarding the development and review of a product. Type C meetings should be scheduled to occur within 75 days of FDA receipt of the written .
What is an industry meeting type?
Industry Meeting Type describes the various types of formal industry meetings that occur. Source. FDA Modernization Act of 1997 Relationship. Industry Meeting Response describes the disposition of the Industry Meeting Type. FDA Specifications. None. CDER Specifications.
What is an example of a type B meeting?
Type B meetings are milestone meetings. According to the FDA’s draft guidance, examples of a Type B meeting include: Post-action meetings when requested within three months after receiving an FDA regulatory action other than approval. Except in the most unusual circumstances, the FDA states that it will honor most Type B meeting requests.