US FDA Portal Open To Receive OTC Monograph Meeting Requests

Submitting other OTC monograph program communications through CDER's NextGen Portal, including proposals to add formulations or indications to a monograph, will have to wait.

An online portal is open for submitting requests for formal meetings with the US Food and Drug Administration on OTC monograph drug proposals and for related meeting correspondence.

Submitting other OTC monograph program communications that must go through the FDA Center for Drug Evaluation and Research’s NextGen Portal,...