Work

Split Real Time Application Review (STAR) (from Catapult's regulatory round-up for November 2024)

Year: 2025

Type: other

Abstract: Under the Prescription Drug User Fee Act (PDUFA) VII Commitment, FDA is creating the STAR pilot program which aims to shorten the time from the date of complete submission to the action date, in order to allow earlier patient access to therapies that address an unmet medical need. FDA will consider an application eligible for the STAR pilot program if each of the following criteria are met: Clinical evidence from adequate and well-controlled investigation(s) indicates that the drug may demon...

Source: Industrias Culturais (Universidade de Coimbra)

DOI: 10.58079/13axp

Author: Adelage

Language: English

Topic: Pharmaceutical Economics and Policy

Subfield: Economics and Econometrics

Field: Economics, Econometrics and Finance

Domain: Social Sciences

SDG: Good health and well-being

Open Access status: green

OpenAlex ID: W6955073852

Cites:

Cited by:

Related to: