Regulations.gov document

Applications for Food and Drug Administration Approval to Market a New Drug; Postmarketing…

Proposed Rule · FDA-2008-N-0341 · posted Sep 29, 2008

Key facts

Document ID FDA-2008-N-0341-0002
Title Applications for Food and Drug Administration Approval to Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs; Companion Document to Direct Final Rule
Document type Proposed Rule
Subtype NPR-Notice of Proposed Rule-Making
Agency FDA
Docket FDA-2008-N-0341
Posted Sep 29, 2008
Federal Register citation 73FR56529
FR document number E8-22829
CFR 21 CFR 314
Comment period opens Sep 29, 2008
Comments due Dec 16, 2008

At a glance

  • 1–9 Pages
  • No Open for comment
  • 1–9 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