Request that the FDA provide an explanation as to why the FDA stated that PGIC is not considered a well-defined and reliable measure of endometriosis-associated pain yet permitted the use of the PGIC as an one of the Instruments used in the Phase 3 trials and used in the evaluation of efficacy of Orilissa (elagolix), including the co-primary | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2025-P-5493

Request that the FDA provide an explanation as to why the FDA stated that PGIC is not considered a well-defined and reliable measure of endometriosis-associated pain yet permitted the use of the PGIC as an one of the Instruments used in the Phase 3 trials and used in the evaluation of efficacy of Orilissa (elagolix), including the co-primary

Documents

Comments

Description

OPEN

Key Dates

Comment Period OpensOct 21, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Interim Response	Apr 28, 2026	--

Keywords

CDER

Citizen Petition

provide an explanation as to why

stated that PGIC is not considered a

well-defined and reliable measure of

endometriosis-associated pain yet permitted

the use of the PGIC as an one of the

Instruments used in the Phase 3 trials

Data from Regulations.gov