FDA Basics Webinar, June 17, 2013: Biological Products: Part 1
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:
- FDA Basics Metrics: June 2015
- FDA Basics Metrics: March 2015
- FDA Basics Metrics: April 2015
- FDA Basics Metrics: May 2015
- FDA Basics Metrics: January 2015
- FDA Basics Metrics: July 2015
- FDA Basics Metrics: February 2015
- Are medical devices regulated for non-medical reasons?
- I am a patient and would like to participate in a clinical study for a new device or procedure. How can I find out more about the study?
- Who can I contact if my question wasn’t answered or if I have additional questions in the future?
- What does ‘recall’ mean?
- What products are regulated as electronic products that emit radiation?
- What is a medical device?
- Who can I contact if my question wasn’t answered or I have additional questions in the future?
- Where can I find more information about a specific type of product?
- What happens when a radiation-emitting electronic product is also a medical device or is used for irradiation or inspection of food?
- Does FDA approve radiation-emitting electronic products?
- What routine requirements apply to manufacturers of radiation-emitting electronic products?
- How does FDA regulate radiation-emitting electronic products?
- How FDA Evaluates Regulated Products: Cosmetics
- Where do I go to report problems with flea and tick products?
- How do I report a pet food complaint?
- How do I report an adverse drug experience (ADE) in an animal?
- I read online that a supplement can treat my dog’s illness. Is the supplement safe to give to my pet?
- Is it safe for me to provide my pet with a raw food diet?
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