New Safety Websites Launched by FDA

The U.S. Food and DrugAdministration (FDA) has launched two new websites relating to drug safety. On its Postmarketing Drug Safety Evaluations site (www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/Surveillance/ucm204091.htm), patients and healthcare professionals can view what the FDA has learned about the safety of new drugs or biologics, such as vaccines, 18 months after approval or after 10,000 patients have used them, whichever comes later.

The second site, the Safety Reporting Portal (www.safetyreporting.hhs.gov), was launched with the National Institutes of Health and is designed to provide greater and easier access to online reporting of safety problems related to foods, including animal feed, animal drugs and adverse events occurring on human gene transfer trials. In the future, the site will encompass other types of clinical trials and, eventually, safety problems arising from products regulated by a broad array of federal agencies.