Agency list in HHS Unified Agenda also states intent to publish before end of 2019 an NPRM to add the common cold indication to certain OTC monograph antihistamine ingredients. Nonbinding timelines also included for NPRM on clarifying regarding when studies to evaluate drug uses of products marketed as foods, supplements or cosmetics are subject to IND reviews.
The US Food and Drug Administration's latest Regulatory Agenda includes the planned publication by May 2020 of a notice of proposed rulemaking to allow firms to submit OTC new drug applications that incorporate extra-label information to help guide consumers' self-selection.
The agency's list in the Department of Health and Human Services