FDA, MIH Launch Electronic Safety Reporting Portal | Healthcare Informatics Magazine | Health IT | Information Technology Skip to content Skip to navigation

FDA, MIH Launch Electronic Safety Reporting Portal

May 26, 2010
by root
| Reprints

The Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have launched the Safety Reporting Portal (SRP), a Web site that will eventually allow for the reporting of pre- and post- market safety data to the federal government.

As of its launch, SRP can currently be used to report safety problems related to foods, animal feed, animal drugs, and adverse events occurring on human gene transfer trials. Trial sponsors can use the portal to prepare a report, print it and send it to the agency to satisfy reporting requirements for investigational new drugs.

The system is planned to eventually encompass other types of clinical trials, and also allow for reporting on safety problems that arise from products regulated by a broad array of federal agencies. The FDA sees this as the first step towards creating a common electronic reporting system that would allow an individual to file a single report to multiple agencies.

The FDA and NIH hope SRP will ultimately enhance the government’s systemic analysis of safety information to greater benefit public health.

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.