Expedited Program for Serious Conditions--Accelerated Approval of Drugs and Biologics; Draft Guidance for Industry; Availability

Documents

Comments

Key Dates

Comment Period OpensDec 6, 2024

Comment Period ClosesApr 8, 2026

Type	Title	Posted	Comments	Status
Notice	Agency Information Collection Activities; Proposed Collection; Comment Request; Expedited Programs for Serious Conditions—Accelerated Approval of Drugs and Biologics FR Doc: 2026-02386	Feb 6, 2026

Total Comments

2024-43

CDER

CBER

OCE

Expedited Program for Serious Conditions

Accelerated Approval of Drugs and Biologics

Draft Guidance for Industry

Availability

OPEN