"Demand for the medications Mounjaro, Zepbound, Ozempic, and Wegovy (GLP-1 drugs) has skyrocketed, but supply shortages and high costs have created opportunities for wrongdoers to cash in and endanger consumers," they wrote.美国食品和药物管理局(Food and Drug Administration)周五宣布,已正式宣布...
您有责任调查和确定任何违规行为的原因,并防止其再次发生或其他违规行为的发生。 如果您正在考虑可能导致您工厂生产的药品供应中断的行动,FDA要求您立即 drugshortages@fda.hhs.gov 联系CDER的药品短缺工作人员,以便FDA与您合作,以最有效的方式使您的运营符合法律。联系药品短缺工作人员还可以让您履行根据 21 U.S.C....
1. 你们公司的质量控制部门未能履行其职责,确保生产的药品符合CGMP并满足既定的鉴别、强度、质量和纯度...
House Panel Presses FDA on Inspections of Indian, Chinese Plants Amid Drug Shortages Republican lawmakers have called on the Food and Drug Administration to explain its foreign inspection programs for drug manufacturers in China and India as shortages continue in the U.S. July 20, 2023· 2 mi...
The FDA added EpiPens to its list of drug shortages in May, citing manufacturing delays and supply disruptions. The Food and Drug Administration has extended the expiration date of some EpiPens to address shortages of the device. The FDA announced Tuesday that select EpiPen...
5.New Survey: 1 in 10 Cancer Patients Has Been Impacted by Nation’s Drug Shortages with Significant Delays to Cancer Care. American Cancer Society Press Release. 19. 10. 2023. 6.E&C Republicans Press FDA Over Inadequate Inspection of Drug Manufacturing in India and China. 18. 07. 2023. ...
FDA Forms Drug Shortages Task Force
5.New Survey: 1 in 10 Cancer Patients Has Been Impacted by Nation’s Drug Shortages with Significant Delays to Cancer Care. American Cancer Society Press Release. 19. 10. 2023. 6.E&C Republicans Press FDA Over Inadequate Inspection of Drug Manufacturing in India and China. 18. 07. 2023. ...
In October, dozens of public health groups urged the White House to take action on the shortage amid a rise in syphilis cases across the country. The FDA’s drug shortagesdatabasesays the supply problem is expected to be resolved in the second quarter of this year. From 2017 to 2021, rep...
In October, dozens of public health groups urged the White House to take action on the shortage amid a rise in syphilis cases across the country. The FDA’s drug shortagesdatabasesays the supply problem is expected to be resolved in the second quarter of this year. From 2017 to 2021, rep...