FDA Takes Actions to Prevent Drug ShortagesJennifer Markarian
, Dec. 6, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA published the draft guidance, "Expedited Program for Serious Conditions — Accelerated Approval of Drugs and Biologics,"...
FDA requests that you contact CDER’s Drug Shortages Staff immediately, at drugshortages@fda.hhs.gov, so that FDA can work with you on the most effective way to bring your operations into compliance with the law. C...
The FDA has declared the shortages as “resolved," removing the drugs from its shortage list. Boxes of Ozempic and Wegovy made by Novo Nordisk are seen at a pharmacy in London, March 8, 2024. Hollie Adams/Reuters In October, a compounding industry group, the Outsourcing Facility...
7月 11, 2024 Dear Mr. Dai: 尊敬的戴先生: The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Jiangsu Hengrui Pharmaceuticals Co., Ltd., FEI 3007373503, at 38 Huanghe Road, Economic and Technological Development ...
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 EpiPe...
A-List: Prioritized Guidance Documents that CDRH Intends to Publish in FY2024 Final Guidance Topics Remanufacturing of Medical Devices Medical Device Shortages - Implementation of Section 506J of the Federal Food, Drug, and Cosmetic Act Marketing Submission Recommendations for A Predetermined Change Contr...
2024年3月7日,恒瑞医药递交了相关说明文件。但经过审查,FDA认为不足以解释问题,最终在7月发出警告信。 1 质控部门未能履行其职责 FDA声称,恒瑞医药的质量控制部门未能履行其职责,确保生产的药品符合CGMP标准,并符合既定的特性、强度、质量和纯度规范(21 CFR 211.22)。
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. ...
Public meeting about drug shortages planned by US FDAPharmacoEconomics & Outcomes News -doi:10.2165/00151234-201106370-00004NoneSpringer International PublishingPharmacoeconomics & Outcomes News