Modernization

FDA wants ideas for transparency

The Food and Drug Administration is asking consumers and industry executives for ideas on how to improve the flow of information about the agency's activities.

Modernization

FDA broadens reach through widgets, content syndication

A widget embedded on partner Web sites drove more than 20 million visitors to FDA.gov to learn more about the peanut recall.

Digital Government

FDA weighs tighter oversight of health IT apps to protect patients

The Food and Drug Administration is considering stepping up its oversight of patient safety related to health IT software, according to an FDA official.

Digital Government

Change comes to FDA's reporting structure

FDA Commissioner Margaret Hamburg elevates the Office of Women's Health so that it now reports directly to her, and creates an Office of Special Medical Programs for pediatric, combination and orphan drugs, as well as an Office of Foods.

Digital Government

Food-safety, public health surveillance IT highlight FDA fiscal 2011 budget request

The Food and Drug Administration wants a 23 percent increase in its budget for fiscal 2011 in part to expand several information technology programs.

Modernization

FDA rolls out Web-based risk assessment tool for food, drug imports

The Food and Drug Administration is launching its automated risk-assessment system that will flag high-risk shipments of imported food and drugs.

Cybersecurity

Obama wants nearly $80B for IT projects

The administration has proposed only a small increase for IT spending in fiscal 2011.

Modernization

NIH Pillbox prototype is easy to digest

The National Institutes of Health's online prototype pill verification system, Pillbox, owes its success to user-centered development, its project manager said.

People

FDA readies new data systems for drug safety

The Food and Drug Administration will expand its tracking of drug safety once the drugs enter the marketplace, according to a new report.

People

FDA plans electronic medical device reports

The FDA has plans to convert its postmarket medical device reporting from paper forms to an electronic system.

Modernization

FDA plans electronic filing for some safety reports

Proposed rules announced today would require that all mandatory post market reporting of adverse effects for drugs and medical devices be filed electronically, either through a gateway, a Web portal under development, or on disk or tape.

People

FDA stumbles toward transparency

Despite having little guidance on how to meet the Obama administration's transparency goals, the Food and Drug Administration is moving forward with plans.

Digital Government

FDA creates info-sharing task force

A new transparency task force at the Food and Drug Administration will recommend ways to share information with the public.

People

GAO: The FDA needs strategic IT plan

The Food and Drug Administration doesn't have a comprehensive strategic plan for managing its numerous IT modernization projects, the GAO reports.

Cybersecurity

GAO: FDA's tracking system isn't secure

FDA's planned Sentinel system for tracking medications and medical devices and their effects on public health has many problems ahead in privacy and security, GAO auditors said.

Cybersecurity

High-risk list adds 3 agencies, scratches 1

The roster of government programs at risk of waste and mismanagement grew to a total of 30 in the latest update from the Government Accountability Office, Congress’ watchdog agency.

People

GAO adds drug safety programs to high-risk list

The FDA program's management weaknesses are aggravated by soaring demand, older computer systems and a lack of clear decision-making processes, auditors report.

Digital Government

FDA said to choose speed when buying IT

The agency entered into risky contracts, the HHS IG says.