Web23 Jun 2024 · Sponsors may email meeting requests to [email protected], with [email protected] in cc line for Regulatory Management Staff awareness. The meeting request should include a... Web6. The sponsor participates in a joint PSA meeting with EMA and FDA during the PSA procedure. In addition, the two agencies will conduct a pre-sponsor meeting tele- or videoconference to further discuss the sponsor’s questions. The two agencies may conduct a post-sponsor tele- or videoconference if needed. On rare occasions staff from
eCFR :: 21 CFR 312.47 -- Meetings.
Web17 Jun 2024 · Meetings between the FDA and the Sponsor can help to ensure that no major CMC strategic surprises could delay the marketing application’s review and approval … Web12 Jan 2024 · A Type D meeting, unlike Type C meetings, will facilitate a discussion between the FDA and a sponsor on one or two defined topics. Due to the narrow focus of the Type D meeting, the overall meeting timelines are more expeditious than those for a … hyperphilly
Five key takeaways from FDA’s 2024 advisory committee meetings
Web5.5K views, 173 likes, 234 loves, 273 comments, 137 shares, Facebook Watch Videos from Hope Channel South Philippines: Live! Panimbaya sa Kabuntagon World with HCSP Family April 8, 2024 WebFormal Meetings with FDA Formal Meetings Meetings provide an important formal forum for communication between sponsors and the CDER review staff about development and … WebObtaining FDA input on a proposed approach through a pre-IND meeting is often very valuable for these studies. In general, sponsors should go through the list of required information for an IND that is codified in US regulations and make use of the large collection of guidance documents the FDA has published. hyperphase glaive