PPMD will present a webinar, WHAT IS AN AD COMM?, on Wednesday, September 2 at 1pm eastern.
Ad Comm. It’s a term our community will be hearing a lot this fall as companies get closer to the possible approval of treatments for Duchenne. But what is an Ad Comm and how does it involve and affect you or your child?
Representatives from FDA will join PPMD staff to help cover the following topics:
- What an advisory committee is/and what it isn’t
- When/why FDA holds committee meetings, when and how they are announced to the public
- Who is on the committee, and role of the patient representative, the role of the chair and theDesignated Federal Officer (DFO)
- Process (sponsor presentation/FDA perspective on data/open public hearing/committee discussion of data and questions/Q. for committee, deliberations, vote and discussions)
- Public input (through open public comments or written comment submission) – including the details of time for the open public hearing, possible limits on number of speakers and time for each to speak (depending on number signing up), how it goes down [speakers notified and assigned in order to speak])
- The types of questions posed by FDA to the committee, the voting procedure, and the value of the committee discussion to the agency
- What's the regulatory procedure AFTER the AdComm? What's the typical timeline? How transparent is that process?
- Does an Advisory Committee recommendation for approval equal approval? Perhaps emphasisHow this is an 'element' of the product review, not the decision point?
You must register to attend this webinar (the webinar is free but registration is required). If you are unable to attend, we will post a link to the webinar afterwards.
To submit your own questions you hope are included on the webinar please send them to firstname.lastname@example.org with “ADCOMM WEBINAR” in the subject line.