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  6. DDI Webinar Series: Overview of the Regulatory Framework and the Development and Approval of Biosimilar Products in the U.S. - December 5, 2017
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DDI Webinar Series: Overview of the Regulatory Framework and the Development and Approval of Biosimilar Products in the U.S. - December 5, 2017

FDA’s Division of Drug Information in the Center for Drug Evaluation and Research (CDER) is excited to present a series of educational webinars targeting the needs of all health care professionals and students, including physicians, physician assistants, nurses, pharmacists, and pharmacy technicians. Interact with FDA staff from a variety of divisions and learn more about the FDA and drug regulation!

On Tuesday, December 5, 2017, CDER's Office of Communication, Division of Drug Information (DDI) hosted a webinar titled: DDI Webinar Series: Overview of the Regulatory Framework and the Development and Approval of Biosimilar Products in the U.S. This webinar provided an overview of the regulatory framework for biosimilar products, including a background, information on terminology and the general requirements of the approval pathway for biosimilars. The webinar also talked about the approach and scientific concepts used in the development of biosimilar products.

View Presentation: https://collaboration.fda.gov/p6nzbmzxao6/

Download Presentation Slides: Biosimilar Products (PDF - 875KB)

Activity Outline and Continuing Education Information: Overview of the Regulatory Framework and the Development and Approval of Biosimilar Products in the U.S. (PDF - 40KB)

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