PPMD Community

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?

 

According to the FDA website, advisory committees (Ad Comms):

provide FDA with independent advice from outside experts on issues related to human and veterinary drugs, vaccines and other biological products, medical devices, and food. In general, advisory committees include a chair, several members, plus a consumer, industry, and sometimes a patient representative. Additional experts with special knowledge may be added for individual committee meetings as needed. Although the committees provide advice to the agency, FDA makes the final decisions.

FDA convenes the Ad Comm meeting and companies participate in order to present their data. There will also be an open-public hearing following the company’s presentation, allowing members of the public to express their opinions about a potential therapy in front of the advisory committee. Occasionally, companies will invite participants to speak on their behalf during the open public hearing to represent various perspectives in the community to the advisory committee. 


To better understand what Ad Comms are, the purpose they serve,
where they fit into the regulatory decision making process, and how we, as the primary stakeholders in the Duchenne community can be most effective during this process, PPMD will host a webinar on September 2 at 1pm eastern to learn more

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 Ad Comm? What's the typical timeline? How transparent is that process?
  • Does an Advisory Committee recommendation for approval equal approval? 


What other topics would you like covered? Please submit questions here:

 info@parentprojectmd.org with “AD COMM WEBINAR” in the subject line.

Register Now

Please register to join us for this important webinar (the webinar is free but registration is required). This is a new step for our community as we get closer to approvals and we all have a critical role to play in this process.

 

Related links

Register for PPMD's Ad Comm Webinar

View the Advisory Committee Calendar

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