该模块下Forms & Submission Requirements(表格和递交要求)项下,包含Drug Master Files (DMFs) 药品主文件(DMFs)及Electronic Regulatory Submission and Review(电子法规提交和审查),点击Drug Master Files (DMFs) 药品主文件(DMFs),进入如下左侧界面,点击List of
点击Drug Master Files (DMFs) 药品主文件(DMFs),进入如下左侧界面,点击List of DMFs,进入如下右侧界面,可以查看DMF清单,每季度更新一次,DMF活动状态(A=激活;I=没激活)、DMF类型、持有人姓名和主题的变化都包括在内。
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...
Earlier this month, the FDA took two other medications used for weight loss, Mounjaro and Zepbound, off its shortage list. Those medications are made by Eli Lilly. Both Ozempic and Mounjaro are approved by the FDA to treat Type 2 diabetes, but some doctors prescribe the medication "off-...
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...
4.1 Clinical Investigator Inspection List (CLIIL) Search 如上图所示,可根据研究者姓名、研究地点、城市、州、国家、邮编、研究类型、研究状态等10种选项进行查询,也可输入关键词进行查询,十分便捷。 4.2 Dissolution Methods Database Search 如上图所示,溶出方法可通过至少3个关键词直接查询,查询的结果包括装置、转...
The FDA Alerts below may be specifically about sodium bicarbonate or relate to a group or class of drugs which include sodium bicarbonate. MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts ...
The following FDA safety notices may be specifically about PulmoSal or relate to a group or class of drugs which include PulmoSal. These notices may include a list of possible medication recalls, market withdrawals, alerts and warnings.
As of June 7, 2023, dulaglutide (Trulicity), semaglutide injection (Ozempic), and semaglutide injection (Wegovy) were all listed as being currently in shortage according to the US Food and Drug Administration (FDA) Drug Shortages list. Still, the desire for the agents has been so great, the...
Prescribers who prescribe the same medication, with the same directions, for the same quantity, for a large number of individuals. ⁋ 81. Prescriptions of drugs or drug combinations that are frequently sought by individuals known to abuse or misuse prescription drugs, including the combination of...