New FDA Web Portal Allows for Patient Questions, Meeting Requests
The US Food and Drug Administration (FDA) on Friday launched an online portal for individual patients, caregivers, advocates, patient groups and health professionals can ask questions or request meetings on any drug, biologic, device or a combination product.The “Request to Connect” portal is now live here.
Co-developed by FDA’s Patient Affairs Staff and the medical product centers, the portal will route inquiries to the appropriate medical product center or office to ensure they are received and responded to.
“As patient populations and their needs evolve and become increasingly complex, Patient Affairs want patients and those who advocate on their behalf to know that our door is open. As a science-based agency, we continue to develop and engage programs that help FDA understand the patient perspective and advance the science of patient input,” FDA said.
The web form is intended to encourage an understanding of and participation in FDA's regulatory work and is not to be used by industry stakeholders, the agency said.
FDA has been increasingly pushing to hear more from patients and to try to integrate the patient perspective into the agency’s work and the approval process. Thanks to the 21st Century Cures Act, FDA last December published draft guidance to help stakeholders submit a proposed draft guidance on patient experience data.
The 12-page draft guidance, which provides information in a Q&A format, addresses questions relating to both guidance development and other potential pathways for contributing patient experience data.
Another draft guidance from last June details how drugmakers can gather comprehensive and representative input from patients.