Risk/Benefit Value Tool Could Trim Guesswork From OTC Switch Attempts
This article was originally published in The Tan Sheet
You may also be interested in...
OTC Switch “Blueprint” Could Help Regulatory Navigation – Researchers
Rx-to-OTC switch questions that FDA asked advisory committees over the past 10 years can help guide future sponsors to success, says the lead researcher in an analysis of the agency’s switch actions.
FDA Advisors Say Greater Insight Needed On Self-Selection Of OTC Statins
More information from "real world" experiences on how consumers make OTC selections may be needed to pull off a successful Rx-to-OTC switch of a statin
FDA Review Of Children’s Cough/Cold OTCs Has Broader Implications
FDA's review of children's over-the-counter cough/cold products will address the broader issue of whether extrapolating pediatric doses from adult dosing data is appropriate