A reviewof FDA’s recall database between 2012 and 2017 demonstrates that at least fourother separate events have occurred with non-sterile aqueous based productsresulting in E. coli contamination.对2012年至 2017年间 FDA召回数据库的回顾表明,至少发生了四起其他非无菌水基药品导致大肠杆菌污染的独立事件...
Thereview of voluntary recall actions during the same time period revealed over 50events associated with objectionable microbiologically contaminated NSDs12. Therecalls showed that a wide range of objectionable microorganisms were found ...
Y. Yan, S. Liu, Q. Zhang and H. Wu, “Analysis of Medical Device Recall Reports in FDA Database in 2005-2006,” IFMBE Proceedings, 2013, pp. 766-769.Y. Yan, S. Liu, Q. Zhang and H. Wu, "Analysis of Medi- cal Device Recall Reports in FDA Database in 2005- 2006," IFMBE ...
to empower stakeholders to better meet regulatory requirements. It encompasses nearly 17,000 tobacco products, including more than 12,000 Pre-existing Tobacco Products category. The database provides detailed information for each listed product, including the product name, manufacturer, categorization...
as Official Action Indicated (OAI), since it is difficult to get a New Drug Application (NDA), Abbreviated New Drug Application (ANDA) or Biologics License Application (BLA) approved when one of the manufacturing facilities in a drug application is listed as OAI on FDA’s inspection database...
If the new recall leads to the device being removed from the market, end-stage heart failure patients could have no options, saidFrancis Pagani, a cardiothoracic surgeon at the University of Michigan who also oversees a proprietary database of HeartMate II and HeartMate 3 implants. ...
美国FDA 指导原则 治疗急性疼痛的非阿片类镇痛剂的开发.工业指南草案工业指南草案 英文原版.pdf,Development of Non- Opioid Analgesics for Acute Pain Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Co
The FDA operates a massivedatabase, called MAUDE, to alert regulators and the public to emerging device dangers. The FDA requires manufacturers to advise the agency when they learn their device may have caused or contributed to a death or serious injury, or malfunctioned in a way that might...
UDIs, submit product information concerning labels to conform to a standard format particularly when provided through devices to FDA’s Global Unique Device to ensure those dates are unambiguous AIDC technology, will allow rapid and Identification Database (GUDID), unless and clearly understood by ...
The FDA has allowed device makers to file 1.1 million reports of injuries or malfunctions to a little-known internal FDA database since 2016, a recent Kaiser Health News investigation has found, spurring top FDA officials to pledge to open those records within weeks and shut down the “alterna...