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  8. FDA Webinar - Overview of the Regulatory Framework and FDA’s Guidance for the Development and Approval of Biosimilar and Interchangeable Products in the US
  1. Therapeutic Biologics Applications (BLA)

FDA Webinar - Overview of the Regulatory Framework and FDA’s Guidance for the Development and Approval of Biosimilar and Interchangeable Products in the US

FDA Webinar - Overview of the Regulatory Framework and FDA’s Guidance for the Development and Approval of Biosimilar and Interchangeable Products in the US

The FDA recorded a webinar titled, “FDA’s Overview of the Regulatory Guidance for the Development and Approval of Biosimilar and Interchangeable Products in the US”. Dr. Sue Lim, M.D., Director of the Scientific Staff, Therapeutic Biologics and Biosimilars Team, CDER, FDA presented information on the regulation and development process of biosimilar and interchangeable products. This webinar was recorded to help FDA Advisory Committee members and Special Government Employees gain insight into the regulatory framework and key concepts about biosimilar and interchangeable products.