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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written...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

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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written...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 FDA Patient Listening Sessions are short meetings that last up to 90 minutes. During the FDA Patient Listening Session, it is important to focus on topics that are related to FDA’s regulatory work. This will ensure that your comments address issues that are most...