Requests that the FDA pursue an expedited, flexible regulatory path forward for DCA as the first and currently only potential treatment for Pyruvate Dehydrogenase Complex Deficiency (PDCD) | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2025-P-7057

Requests that the FDA pursue an expedited, flexible regulatory path forward for DCA as the first and currently only potential treatment for Pyruvate Dehydrogenase Complex Deficiency (PDCD)

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensDec 15, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Final Response Letter from FDA CDER to Frances Pimentel	Apr 23, 2026	--

Keywords

CDER

Citizen Petition

Hope for PDCD Foundation

Requests that the FDA pursue an expedited,

flexible regulatory path forward for DCA as the

first and currently only potential treatment for

Pyruvate Dehydrogenase Complex Deficiency (PDCD)

CLOSED

Data from Regulations.gov