FDA Basics Webinar: A Brief Overview of Risk Evaluation and Mitigation Strategies (REMS)
In 2007, a new law that gave FDA many new authorities and responsibilities to enhance drug safety was enacted. It’s called the Food and Drug Administration Amendments Act- sometimes called “FDAAA”- and one of its provisions gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks.
A REMs may be required by the FDA as part of the approval of a new product, or for an approved product when new safety information arises. Essentially, a REMS is a safety strategy to manage a known or potential serious risk associated with a medicine and to enable patients to have continued access to such medicines by managing their safe use.
Since medicines are very different from each other, each REMS for each medicine is also different.
This presentation will be held on November 20, 2012 at 1:00 PM EST and will discuss REMS and how they are used to help ensure that the benefits of certain medicines continue to outweigh their risks. To join the meeting, click here: https://collaboration.fda.gov/rems1/
For more information, visit the FDA Basics website.
FDA Basics – OCTGT Webinar on Tissue Safety: Materials Available
Thank you to all who were able to participate in FDA’s September 20th webinar that addressed how the agency safeguards the nation’s tissue supply. Ellen Lazarus, MD, CAPT, USPHS, Director, Division of Human Tissues, Office of Cellular, Tissue and Gene Therapies (OCTGT), in FDA’s Center for Biologics Evaluation and Research discussed the current FDA regulations established to ensure a safe and available tissue supply.
For those unable to attend, presentation slides and an archived version of the presentation is available on the FDA Basics website.
Thank you again and we hope you are able to join us for the next FDA Basics webinar!
FDA Basics – OCTGT Webinar on Tissue Safety
Did you know that FDA plays a vital role in ensuring the safety of the nation’s tissue supply?
On Thursday, September 20, 2012 at 1 PM, FDA will host a webinar that addresses how the agency safeguards the nation’s tissue supply. Ellen Lazarus, MD, CAPT, USPHS, Director, Division of Human Tissues, Office of Cellular, Tissue and Gene Therapies (OCTGT), in FDA’s Center for Biologics Evaluation and Research will discuss the current FDA regulations established to ensure a safe and available tissue supply. After the presentation, there will an opportunity to ask questions.
For more information on how to join the webinar, please visit the FDA Basics section of the website. There are a limited number of spots available, however archived material will be available immediately after.
FDA’s Pesticide Program
Most people know pesticides protect growing crops from insect consumption, but did you realize pesticides are used on many other types of food, including dairy and shellfish?
The FDA hosted a webinar “FDA’s Pesticide Program”, on Thursday, August 30, 2012 at 2:00 PM ET. The featured speaker was Capt. Young H. Lee, Ph.D, Office of Food Safety liaison to the Pesticide Monitoring Program at FDA’s Center for Food Safety and Applied Nutrition. This webinar presented FDA’s rules and regulations for pesticide use, and its effect on the consumer.
For more information, including an archived version of the presentation, please visit: http://www.fda.gov/AboutFDA/Transparency/Basics/ucm316688.htm.
FDA Basics Webinar: Recall Process for FDA-Regulated Products
Consumers are impacted by FDA-regulated products daily. Food, medicines, and medical devices are examples of FDA-regulated products. What happens when a potentially harmful item is on the market?
Learn more on Thursday July, 26, 2012 at 3 p. m. ET, in a FDA- hosted webinar ” Recall Process for FDA-Regulated Products.” Recall Coordinator Cecilia Wolyniak of FDA’s Office of Enforcement will discuss the recall process and how recalls are monitored and publicized.
For more information on how to join the webinar, please visit the FDA Basics section of the website. There are a limited number of spots available. Webinar Slides can viewed before the presentation. Archived material will be available immediately after.
Connect With Us: Using FDA’s Digital Tools to Present, Participate, and Personalize Tobacco Information
In this short 30 minute webinar, you will learn how the FDA Center for Tobacco Products uses a variety of digital tools to engage and inform you about tobacco laws and the dangers of tobacco use. From Twitter to texting, digital technology offers countless opportunities to motivate, inspire action and present information in new and interesting ways.
The featured speaker is Michael Murray, a senior social media strategist for the FDA Center for Tobacco Products, who will highlight several innovative tools FDA provides that you can easily use to share information and encourage change. Michael will be joined by Anait Saakyan, a marketing specialist, who will present a number of ways to connect with us via social media.
After the presentation, there will be an opportunity to ask questions.
For information on how to join the webinar, please visit the FDA Basics website. There are a limited number of spots available for the Webinar, however Webinar materials will be made available on the FDA Web site.
Materials Available from FDA Basics Webinar on Hearing Aids
Did you miss the FDA Basics webinar on hearing aids? You can learn about what consumers need to know about hearing loss, hearing aids and the different types, and styles available and how to get the most out of your hearing aids.
Materials from the webinar are now available. We have posted a link to view and listen to the webinar and posted a link to download a copy of the presentation slides.
You can also find materials from past FDA Basics webinars.
