The Food and Drug Administration has made important progress in the last two years toward creating a more effective IT infrastructure, according to a preliminary report by the FDA Science Board’s Subcommittee on Information Technology.
The findings are notable because the panel lambasted the agency two years ago in a report that found that FDA’s computer systems could not support the agency’s main mission.
That earlier report, titled “FDA Science and Mission at Risk,” cited a range of problems, including decentralized and aging network servers, unreliable email systems, woefully inadequate disaster recovery programs and scientific computing capabilities that did not meet basic needs of the scientific staff.
But the most recent findings by committee strike a decidedly more positive tone. “The [agency’s] work greatly exceeded our expectations in terms of how much progress had been made putting together an IT infrastructure,” according to Dr. Sangtae Kim, head of the subcommittee which authored the report. “We saw a budget and a realistic plan to meet the challenges of a data-driven, science-driven agency.”
Kim said advances the FDA made in strengthening the IT infrastructure are largely due to its $2.5 billion, 10-year data center migration program. The Information and Computer Technology for the 21st Century (ICT21) program is a comprehensive, agency-wide IT modernization project that includes data management, data warehousing, IT infrastructure and IT security.
The final report is scheduled to be released in November.
By Elizabeth Laipson
September 25, 2009
Source: Government Health IT
Tuesday, September 29, 2009
Thursday, September 24, 2009
IOM to examine FDA's med device approval process
The Institute of Medicine will undertake a $1.3 million review of the Food and Drug Administration's approval process for certain new medical devices.
The study will examine the FDA notification process for new, low-risk medical devices that have the same use as existing devices and use similar technology or new technology that either does not raise any questions about safety and efficiency, or is at least as safe and effective as products already in the market. Among the medical devices to win approval under the review process this year: a liquid bandage, electronic blood pressure monitor and powder-free latex patient examination gloves.
The IOM, which was commissioned for the analysis, will consider how well the process protects patients and promotes innovation and what changes, if any, would improve results, according to an FDA press release. Meanwhile, the FDA Center for Devices and Radiological Health will undertake its own review "to evaluate and improve the consistency of FDA decision making", according to the release.
Janet Trunzo, executive vice president of technology and regulatory affairs for the Advanced Medial Technology Association, in a written statement, urged the IOM to include experts in medical device innovation and regulation. Trunzo praised the FDA's approval process as "well-defined, science-driven method" and said she believed the review would underscore strengths of the existing system.
The study's results are expected to be released in March 2011.
Melanie Evans / HITS staff writer
The study will examine the FDA notification process for new, low-risk medical devices that have the same use as existing devices and use similar technology or new technology that either does not raise any questions about safety and efficiency, or is at least as safe and effective as products already in the market. Among the medical devices to win approval under the review process this year: a liquid bandage, electronic blood pressure monitor and powder-free latex patient examination gloves.
The IOM, which was commissioned for the analysis, will consider how well the process protects patients and promotes innovation and what changes, if any, would improve results, according to an FDA press release. Meanwhile, the FDA Center for Devices and Radiological Health will undertake its own review "to evaluate and improve the consistency of FDA decision making", according to the release.
Janet Trunzo, executive vice president of technology and regulatory affairs for the Advanced Medial Technology Association, in a written statement, urged the IOM to include experts in medical device innovation and regulation. Trunzo praised the FDA's approval process as "well-defined, science-driven method" and said she believed the review would underscore strengths of the existing system.
The study's results are expected to be released in March 2011.
Melanie Evans / HITS staff writer
Monday, September 21, 2009
Sebelius announces new food safety Web site
The Obama administration is rolling out a new Web site designed to streamline food safety information for consumers.
Health and Human Services Secretary Kathleen Sebelius announced the new Web site — http://www.foodsafety.gov — on Wednesday during the Consumer Federation of America's food policy conference. The site will put food-related information from all federal agencies in one place, including recall and contamination alerts and tips on how to safely handle food.
The Web site is a joint effort between HHS, the Department of Agriculture and the Food and Drug Administration.
Sebelius says the site would help consumers who have been worried about product recalls.
The consumer Web site is the second federal initiative announced in as many days on food safety. On Tuesday, the FDA announced more stringent rules for reporting potential contaminations and the creation of a new electronic database for manufacturers to use to report food safety issues.
Under the new rules, producers are required to report products that could harm consumers within 24 hours.
The law creating the database was passed in 2007, after Congress criticized the FDA for its handling of safety problems involving a variety of food and drugs.
By HENRY C. JACKSON
September 9, 2009
Source: Associated Press
Health and Human Services Secretary Kathleen Sebelius announced the new Web site — http://www.foodsafety.gov — on Wednesday during the Consumer Federation of America's food policy conference. The site will put food-related information from all federal agencies in one place, including recall and contamination alerts and tips on how to safely handle food.
The Web site is a joint effort between HHS, the Department of Agriculture and the Food and Drug Administration.
Sebelius says the site would help consumers who have been worried about product recalls.
The consumer Web site is the second federal initiative announced in as many days on food safety. On Tuesday, the FDA announced more stringent rules for reporting potential contaminations and the creation of a new electronic database for manufacturers to use to report food safety issues.
Under the new rules, producers are required to report products that could harm consumers within 24 hours.
The law creating the database was passed in 2007, after Congress criticized the FDA for its handling of safety problems involving a variety of food and drugs.
By HENRY C. JACKSON
September 9, 2009
Source: Associated Press
FDA Announces Public Hearing on Internet Promotion
After years of refusing to craft Internet-specific policies, the FDA did an abrupt about-face today by announcing a public hearing on the matter.
In a Sept. 21 notice in the Federal Register, the agency detailed plans for a public hearing Nov. 12 and 13 in Washington, D.C. The hearing will "help guide FDA in making policy decisions on the promotion of human and animal prescription drugs and biologics and medical devices using the Internet and social media tools," according to the notice.
During a presentation at a Food and Drug Law Institute-sponsored conference Monday morning, Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, explained that the agency’s goal is to "eventually issue a draft guidance" on the matter.
The announcement follows years of industry complaints about the lack of guidance in the online realm. Those complaints came to a head this spring when the agency crafted 14 Untitled Letters chastising companies for their handling of sponsored links online.
For additional coverage of the FDA initiative, see upcoming issues of the FDA Advertising and Promotion Manual newsletter.
September 21, 2009
Source: FDA.gov
In a Sept. 21 notice in the Federal Register, the agency detailed plans for a public hearing Nov. 12 and 13 in Washington, D.C. The hearing will "help guide FDA in making policy decisions on the promotion of human and animal prescription drugs and biologics and medical devices using the Internet and social media tools," according to the notice.
During a presentation at a Food and Drug Law Institute-sponsored conference Monday morning, Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, explained that the agency’s goal is to "eventually issue a draft guidance" on the matter.
The announcement follows years of industry complaints about the lack of guidance in the online realm. Those complaints came to a head this spring when the agency crafted 14 Untitled Letters chastising companies for their handling of sponsored links online.
For additional coverage of the FDA initiative, see upcoming issues of the FDA Advertising and Promotion Manual newsletter.
September 21, 2009
Source: FDA.gov
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