Image Please follow these steps to request an FDA patient-led listening session:Complete the Patients Ask FDA webform.Enter the information request, including:The health condition, disease, or your specific concern.Your organization/group name, your organization’s...

Disclaimer: Early release articles are not considered as final versions. Any changes will be reflected in the online version in the month the article is officially released. Isla E. Emmen, William C. Vuyk, Andrew J. Lail, Sydney Wolf, Eli J. O’Connor, Rhea Dalvie,...

Image Download PDF Print VersionHelpful Information:FDA Patient Listening Sessions are one way for the patient community to share perspectives with the FDA about their health experiences, preferences, needs, and goals in managing a disease, or condition.Patient...

Disclaimer: Early release articles are not considered as final versions. Any changes will be reflected in the online version in the month the article is officially released. Author affiliation: Yale School of Public Health, New Haven, Connecticut, USA (K. Pham, C....

Submit Comments by 07/07/2025 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written...