FDA's OTC Naloxone Study Is A Starting Point For Other Switches, Not A Roadmap
This article was originally published in The Pink Sheet
CDER has been studying ideas such as pictograms to communicate instructions on administering opioid-reversal medication, but officials can’t predict when new approaches might help enable FDA to propose regulatory changes in the US switch process.
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Patrizia Cavazzoni, who likely represents a somewhat different leadership style for CDER, distinguished herself while leading the center temporarily during the COVID-19 pandemic.
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.
Influencing consumers with facts about health care topics frequently littered with inaccurate advice from non-expert social media sources requires having trust, say consumer health business executives from Bayer, J&J, Sanofi and Taisho Pharmaceutical at the Consumer Healthcare Products Association executive conference. "From a trust perspective, I think that health care is a deeply personal and emotional issue. ... it is definitely important to be fact-based," said Katie Devine, J&J's consumer self-care business global president.