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FDA

Latest Headlines

Latest Headlines

FDA IT modernization efforts in jeopardy, says GAO

The Food and Drug Administration's information technology modernization efforts are largely piecemeal and lack information critical to effective governance. "Without stable leadership and capabilities, the success of FDA's modernization efforts is in jeopardy," says the GAO.

Parting words: Chopra's tips for 'open innovation' success

While "open innovation" may appear to be a bottom-up, organic concept, there are clear processes for best tapping into citizen expertise, according to now-former Federal Chief Technology Officer

White House standards memo sends strong signal, says Saunders

A Jan. 17 White House memo on the importance of private sector involvement in standards-setting sends an important message to federal agencies and foreign governments, said Mary Saunders, director of

FDA issues draft social-media marketing guidelines

The Food and Drug Administration issued Dec. 27 draft guidance (.pdf) for pharmaceutical and medical device companies on the use of "emerging electronic media." FDA officials note that the guidance

IOM pushes for creation of new, HHS-funded health IT agency

Within a year the Health and Human Services Department should stand up a federal agency--the Health IT Safety Council, which should be funded by HHS--to launch an in-depth investigation into the

U.S. unprepared for large-scale virus outbreak

The United States remains unprepared for large-scale or global outbreaks of deadly viruses for which no current medical countermeasures exist, says the Bipartisan WMD Terrorism Research Center. In a

RxNorm should replace NDC in primary care e-prescribing, says Rand

Electronic prescribing done using the Food and Drug Administration-administered National Drug Code identifiers sometimes misrepresent the prescriber's intent through over specification, says the Rand

FDA releases draft guidance on mobile medical apps

Food and Drug Administration draft guidance (.pdf) published July 19 seeks to regulate mobile medical applications that could compromise the functionality of other regulated medical devices. The

FierceGovernmentIT FOIAs OMB TechStat meeting info, Part II

Little information comes out from the Office of Management and Budget that isn't stage managed or carefully fed to media outlets that don't follow the workings of federal information technology

Big data will transform healthcare, says ONC

Big data will revolutionize healthcare, says a new five-year strategic plan from the Office of the National Coordinator for Health Information Technology. The plan, released for public comment on