右侧上方PRODUCTS选项下包括八种类型产品,分别是Food(食品)、Drugs(药品)、Medical Devices(医疗器械)、Radiation-Emitting Products(放射性产品)、Vaccines, Blood, and Biologics(疫苗、血液和生物制品)、Animal and Veterinary(动物和兽医制品)、Cosmetics(化妆品)、Tobacco Products(烟草)...
(RPM)是FDA人员的参考手册,为FDA人员提供了在处理国内和进口监管和执法事务中使用的内部程序信息、Federal Food, Drug, and Cosmetic Act (FD&C Act)(联邦食品、药品和化妆品法(FD&C法))、FDA Compliance Policy Guides (CPG) (FDA合规政策指南(CPG))及 Regulatory Procedures Manual (RPM)(监管程序手册(RPM))...
Food and Drug Administration coverage from STAT includes medical device regulation, food labels, pharmaceutical safety, and innovations in medical AI.
“The number of FDA-approved drug recalls has steadily continued to increase. In 2015, there were more than 4,600 drug and device recalls, and 405 of these products had the potential to cause serious harm or death.” In the case of medical devices, the recalls are usually performed volunta...
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Honest Globe, Inc., FEI 3015667771, at 3605 West Macarthur Boulevard, Suite 701, Santa Ana, from October 4 to 8, 2019. 2019年10月4日至8日,美国FDA检查了你们的...
Most medical devices recently recalled by the Food and Drug Administration because of very serious risks, were initially approved through an expedited process or were exempt from regulatory review. A study to be released in upcoming months states: Out of all the recalled devices over the four ...
The Food and Drug Administration approved the first vaccine for pregnant women to protect their babies against respiratory syncytial virus during their first six months. 3M Co has tentatively agreed to pay more than $5.5 billion to resolve over 300,000 lawsuits claiming it sold the U.S. military...
The Federal Food, Drug, and Cosmetic Act gives FDA the legal authority to approve and regulate drugs for animals. Before a drug company can market an animal drug, the company must get the drug approved by FDA. However, in 2010 at least two veterinary drugs made by Teva Animal Health, Inc...
The Food and Drug Administration Modernization Act of 1997 (FDAMA) extended the use of user fees and focused on streamlining the drug approval process.In 1999, the 35 drugs approved by the FDA were reviewed in an average of 12.6 months, slightly more than the 12-month goal set by PDUFA....
FDA-Reports.com has compiled Food and Drug Administration adverse event reports�the early warning system that the FDA depends on for making recalls�into a series of side effect reports. See what other consumers, healthcare personnel and patients have endured, as well as the number of ...