FDA Announces Adverse-Event Website | Healthcare Informatics Magazine | Health IT | Information Technology Skip to content Skip to navigation

FDA Announces Adverse-Event Website

June 17, 2010
by root
| Reprints

The U.S. Food and Drug Administration (FDA) has unveiled a new website that will serve as a source of information for patients and health care professionals on the safety of recently approved drugs and biologics.

Summaries of FDA safety analyses on recently approved products will now be periodically prepared and posted on the website. Included in the summaries may be information on potentially serious, previously unidentified risks, if any are found during the review, as well as known adverse events that occur more often than they did during clinical studies. The summaries will also include a brief discussion of any steps FDA may be taking to address these safety issues.

Under Section 915 of the Food and Drug Administration Amendments Act of 2007, FDA is required to prepare safety summaries within 18 month after a product’s approval or after it has been used by 10,000 patients, whichever comes later.

Initial summary reports will contain information on drugs and biologics approved since September 2007, including several drugs for infections, hypertension, depression and other conditions.

Topics

News

NewYork-Presbyterian, Walgreens Partner on Telemedicine Initiative

NewYork-Presbyterian and Walgreens are collaborating to bring expanded access to NewYork-Presbyterian’s healthcare through new telemedicine services, the two organizations announced this week.

ONC Releases Patient Demographic Data Quality Framework

The Office of the National Coordinator for Health IT (ONC) developed a framework to help health systems, large practices, health information exchanges and payers to improve their patient demographic data quality.

AMIA, Pew Urge Congress to Ensure ONC has Funding to Implement Cures Provisions

The Pew Charitable Trusts and the American Medical Informatics Association (AMIA) have sent a letter to congressional appropriators urging them to ensure that ONC has adequate funding to implement certain 21st Century Cures Act provisions.

Former Michigan Governor to Serve as Chair of DRIVE Health

Former Michigan Governor John Engler will serve as chair of the DRIVE Health Initiative, a campaign aimed at accelerating the U.S. health system's transition to value-based care.

NJ Medical Group Launches Statewide HIE, OneHealth New Jersey

The Medical Society of New Jersey (MSNJ) recently launched OneHealth New Jersey, a statewide health information exchange (HIE) that is now live.

Survey: 70% of Providers Using Off-Premises Computing for Some Applications

A survey conducted by KLAS Research found that 70 percent of healthcare organizations have moved at least some applications or IT infrastructure off-premises.