Innovation In OTC Switches Takes Multimedia Approach In US FDA Draft Guidance
This article was originally published in The Pink Sheet & The Rose Sheet
Sponsors can point consumers to video displays, website information and mobile apps to help them choose products that have been switched from Rx to OTC. Draft guidance on innovative switch applications to be followed by rule-making in near future.
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Some stakeholders in regulated industries are concerned that without a history as a public agency executive, Stephen Hahn could have an unpredictable tenure as FDA commissioner. Still, consumer health industry trade groups note regulatory topics crucial to the industry's growth and consumer safety should be clear.
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.