Regulations.gov document

Draft Guidance for Industry and Review Staff on Nonclinical Safety Evaluation of…

Notice · FDA-2008-D-0142 · posted Mar 7, 2008

Key facts

Document ID FDA-2008-D-0142-0001
Title Draft Guidance for Industry and Review Staff on Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route; Availability
Document type Notice
Subtype NAD-Notice of Availability of Data
Agency FDA
Docket FDA-2008-D-0142
Posted Mar 7, 2008
Federal Register citation 73 FR 12454
FR document number E8-04481
Comment period opens Mar 7, 2008
Comments due May 7, 2008
Effective date Mar 7, 2008

At a glance

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

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