Regulations.gov document

New Drugs for Human Use; Clarification of Requirements for Patent Holder

Proposed Rule · FDA-1997-P-0417 · posted Nov 21, 2011

Key facts

Document ID FDA-1997-P-0417-0009
Title New Drugs for Human Use; Clarification of Requirements for Patent Holder
Document type Proposed Rule
Subtype Notice of Proposed Rulemaking (NPRM)
Agency FDA
Docket FDA-1997-P-0417
Posted Nov 21, 2011
Federal Register citation 63 FR 11174
FR document number 98 5800
Comment period opens Mar 8, 1998
Comments due Jun 5, 1998

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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