Regulations.gov document

Draft Guidance for Industry: Investigational New Drug Applications; Determining Whether…

Notice · FDA-2010-D-0503 · posted Oct 14, 2010

Key facts

Document ID FDA-2010-D-0503-0001
Title Draft Guidance for Industry: Investigational New Drug Applications; Determining Whether Human Research Studies Can be Conducted Without an Invertigational New Drug Application
Document type Notice
Subtype Notice of Availability
Agency FDA
Docket FDA-2010-D-0503
Posted Oct 14, 2010
Federal Register citation 75FR63189
FR document number 2010-25851
Comment period opens Oct 14, 2010
Comments due Jan 13, 2011
Effective date Oct 14, 2010

At a glance

  • 1–9 Pages
  • No Open for comment
  • 10–99 Public comments on this docket

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