FDA Adjusts Process Used to Collect & Post CVs of Advisory Committee Members

February 8, 2017

FDA Changes Process Used to Collect & Post CVs for Ad Comm Members & Nominees

On Monday, February 6th, the FDA released the new process that will be used to collect and post curricula vitae (CVs) for advisory committee members.  This will help FDA to post the appropriate CVs to its website without removing or redacting any information.  In its notice published in the Federal Register, the Agency stated that “posting CVs without removing or redacting any information will increase the transparency of FDA’s selection of officials who serve on advisory committees, and will ensure greater public access to the qualifications of advisory committee members on an ongoing basis.”

The Agency’s current nomination process for advisory committee members requires each nominee to submit a CV.  In addition, “FDA also requests that existing advisory committee members submit updated versions of their CVs, typically on a yearly basis.”

As part of its new process, the Agency has stated that, in addition to their CV, nominees will now be required to provide “a written consent form stating that, if the nominee is accepted as a member of an FDA advisory committee, the individual consents to the publication of the individual’s CV to FDA’s Web site, without FDA removing or redacting any information.”  Furthermore, this consent form will also require the nominee to confirm that no confidential information is included in their CV, “including information pertaining to third parties that the nominee is not permitted to disclose.”  If a nominee fails to submit the appropriate consent form with their CV, the nomination will be considered incomplete.

In its notice, the FDA states that “the consent form will need to be submitted along with the four other types of documents currently requested as part of the nomination process:

  1. A CV for each nominee;
  2. A written confirmation that the nominee is aware of the nomination (unless self-nominated);
  3. A letter(s) of recommendation; and
  4. For Consumer Representative applications, a cover letter that lists consumer or community organizations for which the candidate can demonstrate active participation.”

FDA is also going to be requiring the submission of a nearly identical consent form by all existing advisory committee members each time an updated version of their CV is submitted to the Agency.

FDA states that “all nominations for new advisory committee members will be required to be submitted through FDA’s Web site at https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm, or any successor system, and the submission will be required to be accompanied by the required consent form, on or after the date of OMB approval for this information collection.”  Furthermore, all existing advisory committee members will be required to submit a consent form when submitting updated CVs starting on March 8th.

For additional information, view FDA’s notice in the Federal Register.

The Weinberg Group has a 35-year track record of helping our clients achieve successful interactions with the FDA and we have the experience you need to do exactly that.  Contact us today to learn more about our services and how we can help you develop and submit a successful application.

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