FDA Office Centralization At HHS Outlined In Bush Budget Request
This article was originally published in The Gray Sheet
Executive Summary
Public and legislative affairs activities based at the Parklawn Building in Rockville, Maryland, including FDA and the Health Resources and Services Administration (HRSA), will be consolidated into one of four Health and Human Services personnel offices by the end of FY 2003
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Japanese administrative reform: Ministry of Health, Labor and Welfare will merge the governmental agency responsible for evaluating claims of substantial equivalence for devices with its counterpart for drugs. Though the name of the new national institute has not been determined, the Japan Association for the Advancement of Medical Equipment and the Organization for Pharmaceutical Safety & Research, both currently administered by the Pharmaceutical and Medical Device Examination Center umbrella agency, are expected to merge with PMDEC in 2004. Additional revisions to the Japanese Pharmaceutical Affairs Law, anticipated in May, will introduce risk-based classification and a "new approach to approval and license." As part of the reforms, JAAME is "studying the certification process of notified bodies in Europe, [will] introduce third-party certification system once conformity is established by MHLW, and will submit an application to be a certifying body," Executive Director Hiroyuki Yanai says March 19 at the Regulatory Affairs Professionals Society Medical Device Conference in San Francisco. Implementation of the new systems could take one to three years...
Regulatory News In Brief
Japanese administrative reform: Ministry of Health, Labor and Welfare will merge the governmental agency responsible for evaluating claims of substantial equivalence for devices with its counterpart for drugs. Though the name of the new national institute has not been determined, the Japan Association for the Advancement of Medical Equipment and the Organization for Pharmaceutical Safety & Research, both currently administered by the Pharmaceutical and Medical Device Examination Center umbrella agency, are expected to merge with PMDEC in 2004. Additional revisions to the Japanese Pharmaceutical Affairs Law, anticipated in May, will introduce risk-based classification and a "new approach to approval and license." As part of the reforms, JAAME is "studying the certification process of notified bodies in Europe, [will] introduce third-party certification system once conformity is established by MHLW, and will submit an application to be a certifying body," Executive Director Hiroyuki Yanai says March 19 at the Regulatory Affairs Professionals Society Medical Device Conference in San Francisco. Implementation of the new systems could take one to three years...
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