(3) Written response only — WRO responses are sent to requesters in lieu of meetings conducted in one of the other two formats described above Face-to-face has significant benefits ●Get a sense of FDA's attitude...
If a written response only (WRO) has been requested or the FDA chooses to provide WRO, the FDA will respond to the meeting request with the date they intend to send the written responses to the sponsor, generally 70 days from the meeting request receipt date. FDA will entertain requests fo...
•Written Response Only(WRO)仅书面答复(WRO)-发送书面答复以代替面对面或虚拟会议。 2 BsUFA 会议 1.Biosimilar Initial Advisory Meeting(生物类似药初步咨询会议)- 初步评估,仅限于一般性讨论是否可以根据《公共卫生服务法》第 351(k...
•Written Response Only(WRO)仅书面答复(WRO)-发送书面答复以代替面对面或虚拟会议。 2 BsUFA 会议 1.Biosimilar Initial Advisory Meeting(生物类似药初步咨询会议)- 初步评估,仅限于一般性讨论是否可以根据《公共卫生服务法》第 351(k)条对特定产品颁发许可证,如果可以,则就开发计划的预期内容提供一般性建议。
Lipella Pharmaceuticals Inc. recently announced the US FDA has granted a Type C meeting request to discuss the company’s proposed Phase-2b clinical trial design for the evaluation of LP-10, an intravesical liposomal formulation of tacrolimus, as a potential treatment for moderate-to-severe ...
FDA issuedtwo complete response letters(“CRLs”) for Regeneron’s application for odronextamab for two lymphoma indications due to the enrollment status of the confirmatory trials. At the time of these CRLs, only a safety lead-in stage had been initiated for the confirmatory study, not the ...
The menu labeling regulations require disclosure of calories on menu and menu boards, and require that other nutrition information (e.g., fat, sugar, protein) be available in written form on the premises and provided to the customer upon request. Notably, the menu labeling regulations do not ...
meeting includes any meeting that is requested by a sponsor or applicant (hereafter referred to as requester(s)) following the procedures provided in this guidance and includes meetings conducted in any format (i.e., face to face, teleconference/videoconference, or written response only (WRO))....
A well- written meeting request that uses the above components as a guide can help the FDA understand and assess the utility and timing of the meeting related to product development or review. Although CBER or CDER will determine the final meeting type (i.e., Type A, Type B, or Type C...
and end up with little usable information six weeks later – the typical timeframe to obtain a Q-Sub written response or meeting. At that point, if they decide to try again, it will be another six weeks for the next response. Instead of helping to move things along, when used this way...