Many 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.
Adobe Connect Webinar Information:
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- FDA Basics Webinar: "Mini-Sentinel," FDA's New Tool for Monitoring the Safety of FDA-Approved Medical Products
- FDA Basics Webinar - April 27, 2015: Drug Trials Snapshots
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- FDA Basics Webinar, June 17, 2013: Biological Products: Part 1
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- FDA's Pesticide Program
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- How did the Federal Food, Drug, and Cosmetic Act come about?
- Materials from Webinar on Access to Investigational Drugs
- How do I find the latest information on the Web site? How do I sign up for e-mails and alerts?
- What is a docket? How do I submit comments to a docket? How do I find comments submitted to a docket?
- Can I buy medical products online? How do I know they're safe?
- FDA Basics Webinar: FDA CBER Mini-Sentinel Program
- FDA Basics Webinar - November 24, 2014: Drug Shortages
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