FDA Initiative for Drug Facts Label for Over-the-Counter Naloxone | Zendy

Barbara R. Cohen | Zendy; Karen Mahoney | Zendy; Elande Baro | Zendy; Claudia Squire | Zendy; Melissa J. Beck | Zendy; Sara Travis | Zendy; Amanda Pike-McCrudden | Zendy; Rima Izem | Zendy; Janet Woodcock | Zendy

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FDA Initiative for Drug Facts Label for Over-the-Counter Naloxone

Author(s) -

Barbara R. Cohen,

Karen Mahoney,

Elande Baro,

Claudia Squire,

Melissa J. Beck,

Sara Travis,

Amanda Pike-McCrudden,

Rima Izem,

Janet Woodcock

Publication year - 2020

Publication title -

new england journal of medicine

Language(s) - Uncategorized

Resource type - Journals

SCImago Journal Rank - 19.889

H-Index - 1030

eISSN - 1533-4406

pISSN - 0028-4793

DOI - 10.1056/nejmsa1912403

Subject(s) - medicine , (+) naloxone , food and drug administration , over the counter , drug , off label use , opioid , key (lock) , opioid epidemic , drug approval , marketing , public relations , pharmacology , business , computer security , medical prescription , receptor , computer science , political science

The opioid crisis highlights the need to increase access to naloxone, possibly through regulatory approval for over-the-counter sales. To address industry-perceived barriers to such access, the Food and Drug Administration (FDA) developed a model drug facts label for such sales to assess whether consumers understood the key statements for safe and effective use.

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