Archive
New FDA Basics Video Available about the Effective and Proper Uses of Medicines and Devices in Children
As part of FDA Basics, FDA has posted a video with Dr. Dianne Murphy, director of FDA’s Office of Pediatric Therapeutics. Dr. Murphy discusses how FDA helps to develop knowledge about the proper and effective use of drugs and devices in children. View the video below.
Materials Available from FDA Basics Webinar on “Generic Drugs”
Did you miss the FDA Basics webinar about generic drugs?
Materials from the webinar are now available on the FDA Basics website.
Check out the “What’s New” box on the FDA Basics homepage to download materials from the webinar. We have posted a link to view and listen to the 30 minute webinar and posted a link to download a copy of the presentation slides.
** There were audio difficulties during the first couple of minutes of the 30 minute webinar.**
You can find materials from past FDA Basics webinars here.
Afia Asamoah, Transparency Initiative Coordinator
Upcoming Event: FDA Basics Webinar on Generic Drugs, Monday, September 27th, 1:00 p.m. ET
Did you know that generic drugs are safe and effective alternatives to brand name drugs? Did you know that generic drugs can reduce the cost of prescription drugs for both consumers and the government?
As part of FDA Basics, FDA is hosting a webinar where you can learn more. The featured speaker Robert West, a supervisory pharmacist in the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research (CDER), will give an overview of generic drug regulation. After the presentation, there will be an opportunity to ask questions.
The free 30 minute webinar will be held on Monday, September 27, at 1:00 p.m. ET.
Sign in early, since there are a limited number of spots available for the webinar. Materials from the webinar will also be made available on the FDA Web site.
Click here for more information about the webinar, including instructions about how to join the webinar.
Afia Asamoah, Transparency Initiative Coordinator
FDA Launches Webpage with Summaries of Safety Data on New Drugs
On Tuesday, June 15, FDA launched a web page where you can find summaries of safety information about recently approved drugs and a brief discussion of any steps FDA may be taking to address any identified safety issues. New drugs approved after September 27, 2007 will receive a safety summary within roughly two years of approval. The summaries address safety risks that were not identified during a drug's development or prior to FDA approval. FDA plans to publish summaries on a quarterly basis.
The first set of safety summaries for 26 products approved in 2008 can be found here.
You can find questions and answers about FDA's plan to post safety summaries here.
Afia Asamoah, Transparency Initiative Coordinator
