上回應對FDA的管理權限提出質疑。

    詳細英文報道：

　The FDA this year has done an inspection sweep through the largest compounding pharmacies after being caught off guard last year when a nationwide fatal meningitis outbreak was tied to a compounder in Massachusetts. But the federal agency is not alone in trying to get>　　The Massachusetts Board of Registration in Pharmacy sent cease-and-desist notices to Medi-Son Solutions in Norwood and sister compounder CarePro in Quincy after an inspection found problems at Medi-Son, according to the Boston Globe. Hearings for the two facilities are in progress. Anne Roach, a spokeswoman for the Massachusetts Department of Public Health said the state stepped up enforcement after last year's outbreak of fungal meningitis that infected hundreds of people and killed dozens who were injected with pain drugs from New England Compounding Center (NECC) of Framingham. She said the state got an extra $1 million to pump up its efforts. It has inspected 37 compounders since the NECC deal, and>　　Neither of the closed compounders are among the more than 50 that the FDA has inspected since the NECC situation blew up. The federal agency is looking at large compounders that operate more like small drug manufacturers and often ship nationally. The FDA is supporting a bill that would establish clear authority of its oversight powers when it comes to compounders. The proposed law would establish a new category of large compounding pharmacies that would have to register with the FDA and report any adverse reactions tied to their drugs. They would not have to meet all of the strict regulations that drug manufacturers do, but the law would prevent them from continuing to make the most complex biologic drugs that are more easily contaminated. They also would have to kick in fees for the privilege of having FDA supervision.

　　Some members of Congress oppose extending the agency's authority, saying it just needs to use the powers it has to do a better job. But a situation that recently played out between the FDA and a compounding pharmacy in Texas is sure to feed the debate. The FDA last week updated a notice to healthcare providers to remind them not to use products produced by NuVision Pharmacy of Dallas. The FDA said questions of sterility were raised during an inspection of the facility. But the compounder is contesting the FDA's authority and findings. In a notice>上一頁12下一頁在本頁顯示剩余內容

免責聲明:凡注明來源本網的所有作品，均為本網合法擁有版權或有權使用的作品，歡迎轉載，注明出處。非本網作品均來自互聯網，轉載目的在于傳遞更多信息，并不代表本網贊同其觀點和對其真實性負責。

> 您可能還會關注的

• 制藥工業-資訊
• 制藥工業-供應
• 制藥工業-求購

·原料藥行業轉變觀念 節能環保是...·原料藥業需轉變觀念 節能環保是...·原料藥出口進入最艱難時期·原料藥生產和出口應嚴格管控·原料藥企結構調整步伐加快·上半年醫藥公司業績提速 研發費...·華海藥業原料藥增長平穩 制劑出...·華海藥業：原料藥業務放緩 制劑...·資訊下午茶：2013中國醫藥外...·中恒集團中期凈利增16% 銷售...·福安藥業二個藥品獲得注冊批件·華海藥業原料藥和制劑產品通過美...

十大評選人物訪談熱點事件更多>>