Monoclonal Antibodies: Streamlined Nonclinical Safety Studies; Draft Guidance for Industry; Availability

Documents

Comments

Key Dates

Comment Period OpensDec 3, 2025

Comment Period ClosesFeb 3, 2026

Type	Title	Posted	Comments	Status
Other	Monoclonal Antibodies: Streamlined Nonclinical Safety Studies Guidance for Industry Draft Guidance	Dec 3, 2025	15

Total Comments

CDER

2025-486

Monoclonal Antibodies

Streamlined Nonclinical Safety Studies

Draft Guidance for Industry

Availability

OPEN