Archive for October, 2010

FDA Basics Video Available about Drug Development for “Minor Use” in Major Species and For Specific Diseases Affecting “Minor Species”

October 27, 2010 1 comment

As part of FDA Basics, FDA has posted a video with Dr. Margaret Oeller, director of  FDA’s Office of Minor Use and Minor Species Animal Drug Development in the Center for Veterinary Medicine.  Dr. Oeller discusses FDA’s role in encouraging drug development for specific “minor uses” in major species and for specific diseases affecting  “minor species,” which include zoo animals, honeybees, game birds, and aquaculture.  There are only seven major species; all other species are considered “minor species.”  View the video below.

Upcoming Event: FDA Basics Webinar on the Food Emergency Response Network (FERN), Tuesday, October 26th, 1:00 p.m. ET

October 20, 2010 9 comments

Did you know that there is an organization of the nation’s regulatory food testing laboratories whose purpose is to detect, identify, respond to and recover from bioterrorism or public health emergencies involving our food supply?

As part of FDA Basics, FDA is hosting a webinar where you can learn more.  The featured speaker, Carl Sciacchitano, Director of the Division of Field Science in FDA’s Office of Regulatory Affairs (ORA), will describe the Food Emergency Response Network (FERN) and its role in protecting the nation’s food supply.  After the presentation, there will be an opportunity to ask questions.

The free 30 minute webinar will be held on Tuesday, October 26, at 1:00 p.m. ET.

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

New FDA Basics Video Available about the Effective and Proper Uses of Medicines and Devices in Children

October 13, 2010 10 comments

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”

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

FDA Information is Now on Facebook and Flickr

October 5, 2010 16 comments

FDA has a new Facebook page at:

The page provides regular updates on FDA news and events as well as federal health safety information of interest to the public.  Share this information with your Facebook friends and leave us posts letting us know what you would like to see.

FDA is also taking its public health message to Flickr.  You can see pictures of FDA scientists and investigators working to protect and promote the public health, and more.  Visit FDA’s Flickr photostream and let us know what you think. 

Afia Asamoah, Transparency Coordinator

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FDA’s Center for Devices and Radiological Health (CDRH) Launches Inspections Database

October 1, 2010 8 comments

Yesterday, as part of the FDA Transparency Initiative, CDRH launched the ‘CDRH Inspections Database’.  The database provides information about medical device inspections that were the responsibility of CDRH from 2008 to the present (approximately 25% of the medical device inspections conducted since 2008).  The database contains information about the firms, types of devices and inspections, and links to warning letters (when available).

You can search the inspection database by various parameters, including company name, inspection type, product code, inspection classifaction, inspection action, and date.  You can find the database here.

We encourage your feedback on the database and welcome your suggestions for additional information you would like to see.  You can provide feedback on the FDA Web site.

Afia Asamoah, Transparency Initiative Coordinator

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