COVID-19 Therapeutics: US FDA Wants Sponsors To Use The Pre-IND Route, Not The Pre-EUA Path

27 May 2020

Providing information in a pre-IND meeting request will facilitate a more efficient development process, agency says in a new guidance; generally, there is insufficient information to assess if and when an emergency use authorization might be appropriate when a sponsor first enters discussions with the FDA.

good better best — A pre-IND meeting request is the best route for sponsors to talk to US FDA about potential COVID-19 therapeutics. • Source: Shutterstock

Sponsors developing potential therapeutics for COVID-19 should begin discussions with the US Food and Drug Administration through an investigational new drug application (IND) meeting request, the agency said in a new guidance that discourages the emergency use authorization (EUA) pathway as an initial means of contact.

Choosing the pre-IND route at the outset is a more efficient approach than seeking a pre-EUA meeting for a drug...