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Quality Considerations for Demonstrating Bio-similarity to Reference Product – What Does FDA Draft Guidance Say?

  • By: Staff Editor
  • Date: March 23, 2012
Webinar All Access Pass Subscription Abstract:

On February 9, 2012, the FDA released draft guidelines about quality considerations in bio-similar product development. These guidelines provide insight into the procedures which are required to show high similarity with an FDA-licensed biological product and are based on key scientific and regulatory factors which should be considered for submission of applications for bio-similar products to the FDA.

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