FDA takes unprecedented step to spur OTC naloxone development

The FDA has, for the first time, proactively developed and tested a product label to encourage development of an over-the-counter version of the opioid overdose antidote naloxone, according to an agency statement.
The agency’s action removes the burden from the companies of creating such labels and conducting studies that show consumers can use a product without a health care professional’s supervision.
“Some stakeholders have identified the requirement to perform these studies as a barrier to development of OTC naloxone products,” Scott Gottlieb, MD, FDA commissioner,

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