Manufacturers Should Submit Data Now for Emergency Use Authorizations

Emergency use authorizations (EUAs) for unapproved medical products or unapproved uses for them may not be issued until after the HHS secretary has declared a public emergency. However, the FDA “strongly encourages” companies with EUA product candidates to submit data before the determination of an emergency, according to a new guidance.

The guidance, issued last week, explains the FDA’s policies for authorizing the emergency use of unapproved products or unapproved uses of approved medical products during certain public emergencies, such as a heightened risk of attack on the public. The range of potential EUA products includes medical devices, drugs and biologic products.

The guidance, “Emergency Use Authorization of Medical Products,” can be seen at www.fda.gov/oc/guidance/emergencyuse.html.