Regulations.gov document

Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products…

Other · FDA-2023-D-2436 · posted Jul 14, 2023

Key facts

Document ID FDA-2023-D-2436-0002
Title Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products - Draft Guidance for Industry
Document type Other
Subtype Guidance
Agency FDA
Docket FDA-2023-D-2436
Posted Jul 14, 2023
Comment period opens Jul 14, 2023
Comments due Nov 14, 2023

At a glance

  • No Open for comment
  • 10–99 Public comments on this docket

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Regulations.gov documents

Regulations.gov holds the rulemaking and other documents federal agencies post for public comment. Only agency documents are published here; public submissions are not.

Source: Regulations.gov (U.S. General Services Administration eRulemaking Program) · Source date:

Browse all Regulations.gov documents