New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers; Draft Guidance for Industry; Availability | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2024-D-4388

New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers; Draft Guidance for Industry; Availability

Documents

Comments

Description

OPEN

Key Dates

Comment Period OpensMar 4, 2026

Comment Period ClosesMay 5, 2026

Documents

Type	Title	Posted	Comments	Status
Notice	New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request FR Doc: 2026-04291	Mar 4, 2026

Comment Statistics

Total Comments

Keywords

CDER

2015-1178

Guidance for Industry

New Clinical Investigation Exclusivity

(3-Year Exclusivity)

Drug Products

Questions and Answers

OPEN

Data from Regulations.gov