Regulations.gov document

Electronic Submission of Expedited Safety Reports from Investigational New Drug-Exempt…

Notice · FDA-2022-D-1173 · posted Aug 3, 2022

Key facts

Document ID FDA-2022-D-1173-0001
Title Electronic Submission of Expedited Safety Reports from Investigational New Drug-Exempt Bioavailability/ Bioequivalence Studies; Draft Guidance for Industry; Availability
Document type Notice
Subtype Notice of Availability
Agency FDA
Docket FDA-2022-D-1173
Posted Aug 3, 2022
Federal Register citation FR 87 47431
FR document number 2022-16599
Comment period opens Aug 3, 2022
Effective date Aug 3, 2022

At a glance

  • 1–9 Pages
  • None 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