If a meeting request is denied, the FDA will notify the requester in writing according to the timelines described in Table 1. The FDA’s letter will include an explanation of the reason for the denial. Denials wi...
(NASDAQ: CRBP) ("Corbus" or the "Company"), a precision oncology company, today announced that an abstract highlighting pre-clinical data on its CRB-601 anti-aVb8 integrin monoclonal antibody has been accepted for presentation as a poster at the 38th Annual Meeting of the Society for...
the teaching point is don’t jeopardize your drug application and your biologic application with the 510K because you’re looking at different review timelines in CDRH with the 510K and as well meeting MDUFMA clock about your drug and your biological...
- 在最初的Pre-IND会议之后,随后的会议包有不同的时间安排 注意哪些FDA审评官将出席会议并做相应准备 - 如果没有提供名单,可向PM索取 ◀Meeting Denied 会议被拒绝▶ If a meeting request is denied, the FDA will notify the...