上回应对FDA的管理权限提出质疑。
详细英文报道：
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>上一页12下一页在本页显示剩余内容
免责声明:凡注明来源本网的所有作品，均为本网合法拥有版权或有权使用的作品，欢迎转载，注明出处。非本网作品均来自互联网，转载目的在于传递更多信息，并不代表本网赞同其观点和对其真实性负责。
> 您可能还会关注的
·原料药行业转变观念 节能环保是...
·原料药业需转变观念 节能环保是...
·原料药出口进入最艰难时期
·原料药生产和出口应严格管控
·原料药企结构调整步伐加快
·上半年医药公司业绩提速 研发费...
·华海药业原料药增长平稳 制剂出...
·华海药业：原料药业务放缓 制剂...
·资讯下午茶：2013中国医药外...
·中恒集团中期净利增16% 销售...
·福安药业二个药品获得注册批件
·华海药业原料药和制剂产品通过美...
十大评选人物访谈热点事件更多>>