FDA “Material Time, Material Extent” Rule May Be Cloudy For Sunscreens
This article was originally published in The Tan Sheet
Executive Summary
Interim marketing for OTC drugs or "conditions" in the U.S. subject to a final or new monograph is barred under FDA's final rule on "material time, material extent" criteria
You may also be interested in...
FDA’s Rosebraugh Says OTC Labeling Studies Should Be More Rigorous
OTC drug manufacturers and FDA should collaborate to raise the quality of actual use and label comprehension studies to the level of clinical trials, according to OTC Drug Division Deputy Director Curtis Rosebraugh, MD
“Time & Extent” Botanical Candidates To Lead Off With Ginger, Valerian?
Ginger and valerian are promising prospects for FDA determinations on OTC drug monograph eligibility under the "material time, material extent" final rule
Interim Marketing Of New Conditions Prohibited Under Proposed Rule
Final monograph status would be required before a new OTC condition could be sold in the U.S. under FDA's proposed rule on "material time, material extent" published in the Federal Register Dec. 20. Interim marketing of conditions deemed eligible for monograph consideration would not be allowed.