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| May 11, 2010 | |
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Agency for Healthcare Research QualityApril 26th and Older Archive (What’s New This Week) May 3rd (What’s New This Week) FDAFDA Announces Draft Revised Guidance on Transparency and Advisory Committees FDA Changes Process for Medical Device Advisory Committees FDA May Not Allow 510(k), 3rd-Party Review For Some Radiation Devices Federal BudgetWashington Budget Report: May 3, 2010 Health ReformPrograms In Health Reform Law May Not Get Funded Institute of MedicineJoint CommissionJoint Commission Online April 28, 2010 Issue Available Online MedicareJAMA: Imaging costs rise for cancer patients, but still comparatively small NRCNIHRadiation SafetySafety Features Should Be Standard On CT, Fluoro Devices, Docs Say Self ReferralHouse panel chairs ask accountability office to probe imaging self-referral Veterans Affairs |
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FDAFDA Announces Draft Revised Guidance on Transparency and Advisory CommitteesThe U.S. Food and Drug Administration today announced draft guidance that would expand transparency and disclosure when the agency grants a conflict of interest waiver to permit an individual’s participation at an FDA advisory committee meeting... [see full article] FDA Changes Process for Medical Device Advisory CommitteesThe U.S. Food and Drug Administration today announced that it will change the way its expert panels review and discuss data and information during public hearings on medical devices under review for premarket approval, effective May 1, 2010... [see full article] FDA May Not Allow 510(k), 3rd-Party Review For Some Radiation DevicesFDA recently signaled that it will implement a stricter approval process for certain radiation therapy devices due to exposure problems resulting from faulty design or misuse, suggesting that a special 510(k) or a third-party review may not be appropriate for these products. Similar to steps FDA has taken through its medical imaging initiative, the agency will hold a public meeting on radiation therapy devices to gather input on new safeguards and possible changes in premarket device testing, according to a letter the agency sent to manufacturers earlier this month... [see full article] Health ReformPrograms In Health Reform Law May Not Get FundedDozens of programs called for in the new health reform law lacked budget offsets in the Senate bill and may not get the tens of millions of dollars in funding they need to get off the ground, House appropriators warned Wednesday... [see full article] Institute of MedicineNational Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group ProgramAdvances in biomedical research continue to create significant opportunities for improving cancer detection, treatment, and prevention. Clinical trials that test the safety and therapeutic benefit of promising treatments are essential in translating new knowledge into tangible benefits for patients with cancer... [see full article] Gustav O. Lienhard AwardThe IOM is now accepting nominations online for the 2010 Lienhard Award. Nominations will be accepted through May 7, 2010... [see full article] Joint CommissionJoint Commission Online April 28, 2010 Issue Available OnlineIn this issue:
MedicareJAMA: Imaging costs rise for cancer patients, but still comparatively smallBased on a study in the April 28 issue of the Journal of the American Medical Association, the use of diagnostic imaging studies in cancer patients covered by Medicare is growing--with the use of PET imaging most significantly increasing--and costs for this patient population are growing at twice the rate of the overall costs of cancer care... [see full article] NRCNRC’s Open Government PlanNRC is requesting comments on their Open Government Plan. The plan includes a number of new initiatives, including increasing the number of NRC meetings that are Webcast live, using a new Web-based Google tool for searching NRC public documents and redesigning our Web site to make it easier for users to find information they need. The NRC has also reopened IdeaScale, a user-friendly tool for increasing public engagement. Under a pilot program, the NRC is using IdeaScale to solicit ideas on how it can improve its transparency, public participation and collaboration. Both the plan and IdeaScale are part of a government-wide initiative to increase the openness of federal agencies. The plan, IdeaScale and more information about Open Government can be found at:http://www.nrc.gov/public-involve/open.html. Please send any comments to Lynne Fairobent, AAPM’s Manager of Legislative and Regulatory Affairs at lynne@aapm.org. NIHGovernors back NIH fundingA bipartisan group of 25 governors is urging the Senate and House Budget Committees to craft a budget resolution that satisfies the president’s budget request of $32.2 billion for the National Institutes of Health, a 3.2 percent increase from last year... [see full article] Radiation SafetySafety Features Should Be Standard On CT, Fluoro Devices, Docs SayIn the same way seatbelts and airbags are mandatory for all cars, available technologies for reducing radiation dose should be required for all medical imaging equipment that uses ionizing radiation, the Society of Interventional Radiology argues... [see full article] Self ReferralHouse panel chairs ask accountability office to probe imaging self-referralAt the request of the American College of Radiology, House Energy and Commerce chair Rep. Henry Waxman (D-CA), Ways & Means Committee chair Rep. Sandy Levin (D-MI), and Ways & Means Subcommittee on Health chair Rep. Pete Stark (D-CA) have called on the General Accountability Office to perform a study regarding the effects of physician self-referral of advanced medical imaging and radiation therapy treatments on Medicare spending... [see full article] Veterans AffairsHealthcare Inspection Review of Brachytherapy Treatment of Prostate Cancer, Philadelphia, Pennsylvania and Other VA Medical CentersOn May 5, 2008, a patient of Philadelphia, PA VA Medical Center (PVAMC) underwent prostate brachytherapy in treatment for prostate cancer and was inadvertently implanted with radioactive seeds of the wrong strength... [see full article] |
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