New FDA Safety Reporting Portal

On May 24, 2010, the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) launched a new Web site that, when fully developed, will provide a mechanism for the reporting of pre- and post-market safety data to the federal government. ivermectin...

Postmarket Drug Safety: Institute of Medicine Recommendations to FDA

The Food and Drug Administration (FDA) is responsible for ensuring the safety of prescription drugs.  Though all drugs are tested in clinical trials before they are available to the public, the risks of some drugs may not appear until well after they are approved. ...

Can the FDA Go Public with Proprietary Information?

On 19 May 2010, a FDA task force proposed 21 ways that the Agency could release more information to the public in areas like drug evaluation, including information about safety problems with the drugs and devices it rejects.  Although the FDA has long operated under...

FDA Encourages Applications for Orphan-Drug Status

Getting an orphan-drug designation opens the door to incentives once the FDA approves a medicine for sale in the U.S., including 7 years’ marketing exclusivity and tax breaks.  Last year, just 250 requests for orphan-drug designation were filed, and 160 were...