Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers; Draft Guidance for Industry; Availability | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2024-D-2581

Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers; Draft Guidance for Industry; Availability

Documents

Comments

Description

Open

Key Dates

Comment Period OpensJul 23, 2024

Comment Period ClosesSep 24, 2024

Documents

Type	Title	Posted	Comments	Status
Other	Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers; Guidance for Industry; Draft Guidance	Jul 23, 2024	7

Comment Statistics

Total Comments

Keywords

CDER

FRDTS # 2023-162

Postapproval Manufacturing Changes to Biosimilar

and Interchangeable Biosimilar Products:

Questions and Answers

Draft Guidance for Industry; Availability

Open

Data from Regulations.gov