WebAug 25, 2024 · An informal meeting An agreement meeting Other (such as submission issues or study risk determinations) The Pre-Submission process was born out of a need to provide expanded access to the FDA and allow companies to … WebYou may request a Pre-Sub meeting in the form of a face-to-face meeting or a teleconference with appropriate FDA personnel, or you may simply request feedback via an email response. The type of meeting is often defined by the type of device and the specific questions being posed to the FDA.
US FDA pre-sub (Q-Sub) consulting for medical devices - Emergo
WebAug 16, 2024 · The FDA will respond to the pre-IND meeting request within 21 calendar days of request receipt. If a meeting is granted the meeting will be scheduled within 60 calendar days from the receipt of request. A … http://www.china.org.cn/world/Off_the_Wire/2024-04/14/content_85228716.htm chadwell make ready board
Formal Meetings Between FDA and Sponsors or …
WebThe European Medicines Agency (EMA) holds regular meetings by phone or videoconference with other non-EU regulators in so-called 'clusters'. The clusters are areas of cooperation focusing on special topics and therapeutic areas identified as requiring an intensified exchange of information and collaboration. WebFormal Meetings with FDA. Submitting a Meeting Request. Submitting a Meeting Package. Tips for Productive Meetings with FDA. Module Review. CDER 21st Century Review. Impact of Formal Meetings with FDA. Meeting Timing. Types of Meetings. WebDec 6, 2015 · Each year, sponsors and FDA engage in thousands of formal and informal communications, including meetings and teleconferences, during the IND phase. At the sponsor’s request, FDA will, if possible, provide advice on specific matters. hans kim tony hinchcliffe