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Posts Tagged ‘Center for Drug Evaluation and Research’

Upcoming Event: FDA Basics Webinar by the Center for Drug Research and Evaluation on the Bad Ads Program, April 28, 2011, at 12 Noon ET

April 15, 2011 12 comments

Did you know that healthcare providers can play an important role in ensuring that prescription drug advertising and promotion is truthful by recognizing and reporting misleading ads?

As part of FDA Basics, FDA is hosting a webinar where you can learn more. Catherine Gray, Pharm.D., in the Division of Drug Marketing, Advertising, and Communication (DDMAC) in FDA’s Center for Drug Research and Evaluation will present an overview of the FDA’s “Bad Ad” program, specifically focusing on how to identify misleading prescription drug promotion and report this activity to the agency.

The free 30 minute webinar will be held Thursday, April 28 at 12 noon ET.

There are a limited number of spots available for the webinar. Materials from the webinar will also be made available on the FDA website following the presentation.

Learn more about the webinar, including instructions about how to join the webinar.

 

Ann Witt, Transparency Initiative Coordinator

Materials Available from FDA Basics Webinar on “Generic Drugs”

October 7, 2010 9 comments

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

September 20, 2010 3 comments

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

June 17, 2010 14 comments

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

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