Regulations.gov document

New and Revised Draft Q&As on Biosimilar Development and the Biologics Price Competition…

Notice · FDA-2011-D-0611 · posted Dec 12, 2018

Key facts

Document ID FDA-2011-D-0611-0065
Title New and Revised Draft Q&As on Biosimilar Development and the Biologics Price Competition and Innovation Act (Revision 2); Draft Guidance for Industry; Availability
Document type Notice
Subtype Notice of Availability
Agency FDA
Docket FDA-2011-D-0611
Posted Dec 12, 2018
Federal Register citation 83 FR 63898
FR document number 2018-26852
Comment period opens Dec 12, 2018
Comments due Feb 12, 2019
Effective date Dec 12, 2018

At a glance

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

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