Regulations.gov document

Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission…

Proposed Rule · FDA-2008-N-0334 · posted Aug 21, 2009

Key facts

Document ID FDA-2008-N-0334-0001
Title Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements
Document type Proposed Rule
Subtype NPR-Notice of Proposed Rule-Making
Agency FDA
Docket FDA-2008-N-0334
Posted Aug 21, 2009
Federal Register citation 74FR42184
FR document number E9-19682
CFR 21 CFR 600;314;21 CFR 310
Comment period opens Aug 21, 2009
Comments due Nov 20, 2009

At a glance

  • 10–99 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.

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