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 28 Aug 2019
Australian Public Assessment Reports for prescription medicines
28 August 2019 - TGA is reviewing the operation of transparency measures and are considering activities to increase transparency of ...
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 30 Jul 2019
Reforms to the generic medicine market authorisation process
30 July 2019 - The TGA would like to thank respondents who provided submissions in response to the public consultation ...
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 14 Apr 2019
Use of multiple sclerosis medicine Lemtrada restricted while EMA review is ongoing
12 April 2019 - EMA has started a review of the multiple sclerosis medicine Lemtrada (alemtuzumab) following new reports of ...
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 26 Feb 2019
Procedural update on submission of Type I variations to EMA in March, April and May 2019
26 February 2019 - EMA is encouraging marketing authorisation holders intending to submit Brexit-related Type IA and Type IB variations ...
Posted by Michael Wonder on 27 Sep 2018
TGA annual performance statistics report: July 2017 to June 2018
27 September 2018 - The statistics contained within this report cover the period 1 July 2017 to 30 June 2018, ...
Posted by Michael Wonder on 24 Sep 2018
EMA to launch new corporate website on 27 September 2018
24 September 2018 - Fresh design and improved features to provide better user experience ...
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 ...