Monthly Archives: July 2013

  • Food & Drug Administration - Learn the basics

    FDAMany of today’s important medications are biological products, generally derived from living material from humans, animals, or microorganisms.  These products treat conditions such as rheumatoid arthritis, anemia, low white blood cell counts, inflammatory bowel disease, and various forms of cancer.  Unlike other drugs known as small molecule drugs, biological products are generally highly complex in structure.  This webinar is designed to provide an overview of biological products and how they differ from small molecule drugs.  Information from this webinar provides helpful background for an enhanced understanding of a future FDA Basics webinar, scheduled for August 19, 2013, on “Biosimilar Biological Products.”  Biosimilar biological products or biosimilars are biological products that are similar to or interchangeable with another FDA-approved biological product.  In 2010, the Obama Administration passed the Biologics Price Competition Innovation Act, designed to encourage the development of biosimilar biological products which can enhance competition and may lead to better patient access and lower cost to consumers.

    ~  Webinar  - Overview of Biological Products

    Did you know that many of our medications for rheumatoid arthritis, anemia, cancer, and other diseases are biological products?

    Learn how these products—derived from living material from humans, animals or microorganisms—work.

    The Food and Drug Administration (FDA) webinar, "Overview of Biological Products,”  Mantej (Nimi) Chhina, M.S., Ph.D., of FDA’s Center for Drug Evaluation Research, explains how these products differ from small molecule drugs.

    Information

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