Blog
RSS FeedPosted by Michael Wonder on 24 Jan 2019
FDA statement from Commissioner announcing efforts to improve the quality of the information used to assess the effectiveness of REMS programs in supporting the safe use of medications
24 January 2019 - In making decisions about whether the benefits of a drug outweighs its risks, there are many ...
Posted by Michael Wonder on 17 Jan 2019
FDA issues letter about paclitaxel coated balloons and eluting stents
17 January 2019 - Today the FDA issued a letter to health care providers about a recent publication in the Journal ...
Posted by Michael Wonder on 09 Jan 2019
The future of FDA's electronic safety surveillance
9 January 2019 - The U.S. FDA is an information-driven agency that requires robust data to make regulatory decisions. ...
Posted by Michael Wonder on 08 Jan 2019
CDER’s work to ensure drug safety is an ongoing top priority
8 January 2019 - Yesterday, I reflected on the FDA’s Center for Drug Evaluation and Research’s wide array of new ...
Posted by Michael Wonder on 26 Nov 2018
Statement from FDA Commissioner and Director of the Center for Devices and Radiological Health on transformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices
26 November 2018 - Forty-two years ago, Congress passed the law establishing the framework for evaluating the safety and effectiveness of ...
Posted by Michael Wonder on 17 Oct 2018
FDA and DHS increase coordination of responses to medical device cybersecurity threats under new partnership; a part of the two agencies’ broader effort to protect patient safety
16 October 2018 - As part of the Administration’s ongoing efforts to strengthen cybersecurity in health care, the U.S. FDA ...
Posted by Michael Wonder on 05 Sep 2018
Statement from FDA Commissioner on the agency’s global efforts to help assure product quality and transparency at foreign drug manufacturing facilities
5 September 2018 - Over the past 25 years, globalisation of drug manufacturing has prompted the FDA to change its ...
Posted by Michael Wonder on 13 Aug 2018
Gottlieb: FDA will streamline drug safety evaluations
10 August 2018 - The FDA will soon standardise the way it handles data on the safety and effectiveness of ...
Posted by Michael Wonder on 26 Jul 2018
FDA announces two initiatives to modernise drug quality programs
26 July 2018 - Patients expect and deserve high-quality drugs – this means consistently safe and effective medicines, free of defects ...
Posted by Michael Wonder on 17 Jul 2018
Are 'breakthrough' drugs as safe as other FDA approved medicines?
17 July 2018 - New research questions the quality of drugs given the "breakthrough therapy" designation by the US FDA. ...
Posted by Michael Wonder on 22 Jun 2018
FDA alerts health care professionals and oncology clinical investigators about an efficacy issue identified in clinical trials for some patients taking Keytruda (pembrolizumab) or Tecentriq (atezolizumab) as monotherapy to treat urothelial cancer with low expression of PD-L1
20 June 2018 - The FDA is restricting the use of Keytruda and Tecentriq for patients with locally advanced or ...
Posted by Michael Wonder on 16 May 2018
Evolving landscape of US FDA drug approval in the era of precision oncology: finding the right balance between access and safety
15 May 2018 - Since 1992, the US FDA has implemented several programs for streamlined review and approval of agents that ...
Posted by Michael Wonder on 19 Apr 2018
FDA staff raises safety concerns over Lilly/Incyte arthritis drug
19 April 2018 - An experimental rheumatoid arthritis drug developed by Eli Lilly and Incyte poses serious risks of deadly blood ...
Posted by Michael Wonder on 17 Apr 2018
FDA medical device safety action plan now available
17 April 2018 - FDA's vision to protect patients and promote public health. ...
Posted by Michael Wonder on 15 Apr 2018
Ironed out
12 April 2018 - During the early part of the 20th century, the growing scientific knowledge that certain diseases were caused ...