ACI's 5th Annual conference on Biosimilars


  When: Wednesday, June 04 to Friday, June 06, 2014 Where:  InterContinental New York Barclay, New York, NY To learn more, visit:   

       Industry News 

Guidance for Industry  Formal Meetings Between the  FDA and Biosimilar  Biological Product Sponsors  or Applicants

This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of  the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA  staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call  the appropriate number listed on the title page of this guidance… [ Read More ]