Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017; Revised Guidance for Industry; Availability

Streszczenie

The Food and Drug Administration (FDA or we) is announcing the availability of a revised final guidance for industry entitled "Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017," which supersedes the now withdrawn final guidance issued in May 2018 (May 2018 guidance). This revised final guidance concerns FDA's implementation of the Prescription Drug User Fee Amendments of 2017. In particular, this revised final guidance removes section VI.B. contained in the May 2018 guidance, regarding the "same product as another product" prescription drug program fee exception for certain prescription drug products under the Federal Food, Drug, and Cosmetic Act.