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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written...

Image Planning for an FDA patient-led listening session typically takes four to six months. After the Patient Listening Session has been scheduled, the patient(s)/organization who requested the listening session should:Work with other patient organizations/groups...

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. Diagnostic Accuracy of 3 Mpox Lateral Flow Assays for Antigen Detection, Democratic Republic...