The U.S. Food and Drug Administration (FDA) announced on Monday to industry and public health stakeholders that draft guidance entitled “Emergency Use Authorization of Medical Products and Related Authorities” was now available.
The purpose of “Emergency Use Authorization of Medical Products and Related Authorities” is to communicate the FDA’s current line of thinking on policies regarding the authorization of the emergency use of certain medical products under the Federal Food, Drug and Cosmetic Act, as well as sections amended or added by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA).
PAHPRA was designed the strengthen the ability of the U.S. to sustain national preparedness for public health, military and domestic emergencies involving chemical, biological, radiological and nuclear agents, including emerging infectious disease threats.
Certain sections of the Federal Food, Drug and Cosmetic Act added by PAHPRA empower the FDA to streamline and facilitate the use of certain approved products in situations where emergency use is necessary without going through the typical approval process.