Comment from Berger Mitchell
AnonymousSupportIndividual
Summary: Mitchell Berger, commenting in a personal capacity, supports the FDA's Patient-Focused Drug Development (PFDD) meetings and suggests several improvements to the program. He recommends that the FDA commit staff to attend both FDA-led and externally-led meetings, standardize expectations and templates for external meetings, provide a list of suggested meeting topics to address unmet needs, and enhance collaboration with other government agencies and the Center for Devices and Radiological Health.
Dear Mr. Gabbour: I write to make the following comments and suggestions in response to the above Request for Information and Comments (RFIC). Please note that the views expressed are mine alone and not those of an agency, organization or other individual(s). Specifically, I recommend that: FDA should commit to staff subject matter experts, external relations and/or CDER Professional Affairs and Stakeholder Engagement (PASE) Staff participating in both FDA-led and externally-led Patient-Focused Drug Development (PFDD) meetings; Standardize expectations for externally-led PFDD meetings; Provide a list of suggested or potential PFDD meeting topics; and Enhance collaboration within FDA and with other partners on PFDD meetings and activities. Full comment attached. Sincerely, Mitchell Berger