Regulations.gov document

Draft Guidance for Industry on Biosimilars: Questions and Answers Regarding Implementation…

Notice · FDA-2011-D-0611 · posted Feb 15, 2012

Key facts

Document ID FDA-2011-D-0611-0001
Title Draft Guidance for Industry on Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009; Availability
Document type Notice
Subtype Notice of Availability
Agency FDA
Docket FDA-2011-D-0611
Posted Feb 15, 2012
Federal Register citation 77FR8885
FR document number 2012-03549
Comment period opens Feb 15, 2012
Comments due Apr 17, 2012
Effective date Feb 15, 2012

At a glance

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

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