Upcoming Webinar to Inform Public About Access to Investigational Drugs

First in the 'FDA Basics' Series of Online Sessions for the Public

SILVER SPRING, Md., Feb. 19 /PRNewswire-USNewswire/ -- Do you have questions about the use of investigational drugs for treatment purposes? Here is your opportunity to ask experts from the Food and Drug Administration (FDA) about this important topic, or to just listen in to learn more about investigational drugs.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

When: Tuesday, Feb. 23, 2010, at 3 p.m. ET

Where: https://webmeeting.nih.gov/expandedaccess/

Host: FDA's Office of Special Health Issues (OSHI), 301-827-4460, [email protected]

Speakers:

Richard Klein, HIV/AIDS program director, OSHI

Theresa Toigo, R.Ph., M.B.A., director, OSHI

Also known as experimental drugs, investigational drugs are new drugs that are in the process of being tested for safety and effectiveness. They either have not yet been approved by FDA, or are approved drugs that have not yet been approved for a new use.

Investigational drugs may sometimes be used outside of clinical trials to treat a patient with a serious or immediately life-threatening disease or condition who has no other comparable or satisfactory treatment options. This use is called expanded access, or "compassionate use."

During this webinar, FDA experts will present information on

• factors to consider in deciding whether to seek access to an investigational drug
• ways to access investigational drugs
• how the agency protects patients using investigational drugs

The presentation will run 30 minutes and will include an opportunity to ask questions.

To join the webinar:

1. Click https://webmeeting.nih.gov/expandedaccess/ (or cut and paste it into your Internet browser).
2. Click "Enter as a Guest," fill in your name, then click "Enter Room."
3. Once you enter the meeting room, a popup will appear inviting you to join the teleconference. Type your own telephone number, then click "Call my phone" or "Call me." Answer your phone when it rings and follow the voice prompts to join the teleconference.

NOTE: If your phone number includes an extension, or if you will attend the teleconference only (not the online visual portion), please use the manual dial-in number: 1-866-628-8620 and passcode: 340910

To verify your ability to access the webinar (recommended for first-time Connect users):

1. Click http://nihbreeze.cit.nih.gov/common/help/en/support/meeting_test.htm (or cut and paste it into your Internet browser).
2. If any failures are indicated, click "Send Results" to submit your test results to Tech Support. Then e-mail [email protected] and indicate that you would like assistance with troubleshooting your computer.

This webinar is the first in a series of monthly online sessions hosted by different FDA centers and offices. The webinar series is part of FDA Basics, a Web-based resource aimed at helping the public better understand what the agency does.

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SOURCE U.S. Food and Drug Administration