Blog
RSS FeedPosted by Michael Wonder on 25 May 2020
WHO pauses trial of hydroxychloroquine in COVID-19 patients due to safety concerns
26 May 2020 - The World Health Organisation has suspended testing the malaria drug hydroxychloroquine in COVID-19 patients due to ...
Posted by Michael Wonder on 25 Apr 2020
FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems
24 April 2020 - Close supervision is strongly recommended. ...
Posted by Michael Wonder on 08 Jan 2020
Abuses of FDA regulatory procedures - the case of Suboxone
8 January 2020 - The manufacturer of brand-name buprenorphine products exploited various FDA regulatory procedures to impede market entry of generic ...
Posted by Michael Wonder on 04 Jan 2020
FDA’s deadline problem?
3 January 2020 - Rush to meet end-of-year drug-approval deadlines leads to more adverse effects, new study shows. ...
Posted by Michael Wonder on 07 Nov 2019
Statement on the agency’s efforts to protect patients through post-market drug safety surveillance practices
6 November 2019 - Public health and safety is the highest priority at the U.S. FDA. ...
Posted by Michael Wonder on 30 Jul 2019
FDA requires box warnings for Pfizer drug Xeljanz
26 July 2019 - Patients taking 10 mg dose twice a day could experience a higher risk of blood clots or ...
Posted by Michael Wonder on 29 Jul 2019
Harms from uninformative clinical trials
25 July 2019 - Individuals who enroll in clinical trials do so with the belief that their participation will help ...
Posted by Michael Wonder on 11 Jul 2019
Ensuring patient safety and drug manufacturing quality through partnership with European Union regulators
11 July 2019 - The Mutual Recognition Agreement with the European Union allows FDA to more effectively deploy our inspectional resources ...
Posted by Michael Wonder on 23 Jun 2019
Statement on agency’s efforts to increase transparency in medical device reporting
21 June 2019 - In the spirit of promoting public transparency, the U.S. Food and Drug Administration’s Center for Devices ...
Posted by Michael Wonder on 29 May 2019
Health advocate says FDA must walk a 'fine line' to ensure affordable drugs are safe
29 May 2019 - Public health advocate Dinesh Thakur said in an interview that aired Wednesday that the FDA is ...
Posted by Michael Wonder on 20 May 2019
FDA's strengthened global inspection program helps ensure generic drug safety
17 May 2019 - Consumers must have confidence in the safety and quality of generic medicines. ...
Posted by Michael Wonder on 10 May 2019
Allegations of widespread fraud raise questions about the safety of generic drugs made overseas
10 May 2019 - It is something we've all heard before: generic drugs are the same as brand-name drugs. They ...
Posted by Michael Wonder on 07 Mar 2019
Many local governments shrug off FDA warning about Canadian drug imports
7 March 2019 - Cities and local governments in several states said they will continue to use a Canadian company ...
Posted by Michael Wonder on 12 Feb 2019
Statement from FDA Commissioner on ongoing efforts to stop the spread of illicit opioids, further secure the U.S. drug supply chain and forcefully confront opioid epidemic
12 February 2019 - The opioid epidemic continues to be one of the greatest challenges facing this nation and the FDA. ...
Posted by Michael Wonder on 08 Feb 2019
FDA takes new steps to adopt more modern technologies for improving the security of the drug supply chain through innovations that improve tracking and tracing of medicines
7 February 2019 - A key element of the U.S. FDA’s mission is focused on helping to ensure that all ...