Regulations.gov document

Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics…

Notice · FDA-2011-D-0611 · posted May 13, 2015

Key facts

Document ID FDA-2011-D-0611-0055
Title Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009; Draft Guidance for Industry; Availability
Document type Notice
Subtype Notice of Availability
Agency FDA
Docket FDA-2011-D-0611
Posted May 13, 2015
Federal Register citation FR 80 27321
FR document number 2015-11528
Comment period opens May 13, 2015
Comments due Jul 14, 2015
Effective date May 13, 2015

At a glance

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

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