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Reston, VA


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FDA Presentations

Preview Past FDA Speaker Presentations

Top Ten List of Analytical Inadequacies in IND and BLA Submissions
Alfred Del Grosso
Team Leader, Analytical Chemistry

Regulatory Perspective on Comparability Assessments of Biotechnology Products
Audrey Jia, M.D., Ph.D.
Division of Monoclonal Antibodies

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Well Characterized Biologicals


Ensure CMC Success through Novel Characterization Strategies and Regulatory Guidance

November 09-10, 2015 · Hyatt Regency Reston · Reston, VA


Alternative Language Options:

  • Japanese
  • Korean
  • Taiwanese
  • Chinese
  • English

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