Blog
RSS FeedPosted by Michael Wonder on 06 Jan 2020
Novel drug approvals for 2019
2 January 2020 - How many of the 'novel' drugs approved by the FDA in 2019 are actually new medicines in ...
Posted by Michael Wonder on 28 Aug 2019
Academics and researchers raise concerns with FDA’s plan for ‘integrated reviews’
28 August 2019 - More than 50 academics and researchers from Harvard, Yale, Johns Hopkins and other universities around the ...
Posted by Michael Wonder on 07 Aug 2019
FDA should take additional steps to address factors that may affect approval rates in the first review cycle
7 August 2019 - Companies that make generic drugs—which have the same active ingredients as brand-name drugs—have to apply for ...
Posted by Michael Wonder on 29 Jul 2019
FDA’s Sharpless outlines FDA's 4 top priorities: tech, hiring, modernisation and increased safety
24 July 2019 - Acting U.S. FDA Commissioner Ned Sharpless emailed agency staff yesterday outlining the FDA’s four main priorities. ...
Posted by Michael Wonder on 23 Jul 2019
U.S. District Court orders FDA to reconsider application for final approval of Brixadi (buprenorphine) extended release injection for the treatment of opioid use disorder
23 July 2019 - The U.S. District Court for the District of Columbia granted Braeburn’s motion for summary judgment, vacating ...
Posted by Michael Wonder on 07 Jul 2019
Fast-track drug approval, designed for emergencies, is now routine
5 July 2019 - Three-quarters of new drugs get an expedited regulatory review, thrusting families and doctors into a new world ...
Posted by Michael Wonder on 20 Mar 2019
FDA reform: it’s time to act, but not as an independent agency
19 March 2019 - In a rare exercise in bipartisan leadership, former FDA commissioners of both political parties called, in ...
Posted by Michael Wonder on 19 Sep 2018
FDA smashes record for most ANDA complete responses in one year
19 September 2018 - The US FDA has issued more complete responses for abbreviated new drug applications in 2018 than ...
Posted by Michael Wonder on 31 Aug 2018
Statistical analysis of patient-reported outcome data in randomised controlled trials of locally advanced and metastatic breast cancer: a systematic review
1 September 2018 - Although patient-reported outcomes, such as health-related quality of life, are important endpoints in randomised controlled trials, there ...
Posted by Michael Wonder on 05 Jun 2018
FDA proposes process modernisation to support new drug development
4 June 2018 - The staff of the FDA’s Center for Drug Evaluation and Research (CDER) always tries to utilise cutting-edge ...
Posted by Michael Wonder on 05 Jun 2018
Postmarket studies required by the US FDA for new drugs and biologics approved between 2009 and 2012: cross-sectional analysis
24 May 2018 - Between 2009 and 12, the FDA approved 97 new drugs and biologics for 106 indications with at ...
Posted by Michael Wonder on 11 Apr 2018
The FDA breakthrough-drug designation — four years of experience
12 April 2018 - In 2012, Congress created the breakthrough-therapy designation to expedite the testing and approval by the FDA of ...
Posted by Michael Wonder on 22 Feb 2018
Federal right-to-try legislation — threatening the FDA’s public health mission
22 February 2018 - A bill passed by the Senate would sharply curtail the FDA’s oversight of access to investigational drugs. ...
Posted by Michael Wonder on 08 Feb 2018
Rejuvenating regenerative medicine regulation
7 February 2018 - The FDA recently made long-awaited progress toward protecting patients from interventions involving human cell- and tissue-based products ...
Posted by Michael Wonder on 23 Jan 2018
The one year anniversary of the Oncology Center of Excellence
19 January 2018 - One year ago, 19 January 2017, FDA officially launched the Oncology Center of Excellence to leverage the ...