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What is the difference between a Type C and a Type D meeting?
Note: Type C meetings include meetings to discuss early consultation on the use of new surrogate endpoints. 5. Type D Meeting - A meeting focused on a narrow set of issues (should be limited to no more than 2 focused topics) and should not require input from more than 3 disciplines or Divisions.
What does FDA mean in public health?
The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nations food supply, cosmetics, and products that emit radiation.
Are FDA meetings public?
Public meetings held at FDA White Oak are often webcast live and recorded. For FDA advisory committee meetings check the advisory committee website for webcast information.
What is a Type C meeting with FDA?
Type C FDA meetings are a catch-all category and include 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 an example of a Type C meeting?
Type C meetings are meetings that cover any topic not otherwise covered by a Type A, Type B, or Type B (EOP) meeting regarding the development and review of a product. Examples include: End-of-phase 2A (EOP2A) meetings. OTC Monograph Feedback (560FB) meetings.
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Type-C Meeting means a type C meeting, including face-to-face, by teleconference, or video conference, within the meaning of the Guidance for Industry, Formal Meetings between the FDA and Sponsors or Applicants as published by the U.S.
What are the three types of FDA meetings?
Meeting types The guidance describes the different meeting categories: Type A, B, C and Type D and INTERACT meetings. Type A meetings are for products with stalled development programs or for resolving disputes.
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