Blog
RSS FeedPosted by Michael Wonder on 02 May 2018
EMA 2017 annual report published
2 May 2018 - Report highlights major achievements and includes key figures ...
Posted by Michael Wonder on 24 Apr 2018
EMA publishes agenda for 23-26 April CHMP meeting
23 April 2018 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 17 Apr 2018
Final minutes of December 2017 EMA/EUnetHTA meeting
16 April 2018 - The EMA has published the final minutes from the 15 December 2017 meeting. ...
Posted by Michael Wonder on 12 Apr 2018
FDA finalises guidances to accelerate the development of reliable, beneficial next generation sequencing-based tests
12 April 2018 - The agency is leveraging new tools and policies to advance the creation of innovative genetic and genomic-based ...
Posted by Michael Wonder on 03 Apr 2018
Half yearly performance snapshot: July to December 2017
3 April 2018 - The TGA has maintained a high level of activity while also progressing regulatory reforms over the reporting ...
Posted by Michael Wonder on 30 Jan 2018
Prescription medicines and biologicals: TGA annual summary 2017
30 January 2018 - This is TGA's fourth annual summary report on the registration of prescription medicines, which includes new generic ...
Posted by Michael Wonder on 29 Jan 2018
FDA approved record number of generic drugs last year
26 January 2018 - The FDA approved 1,027 generic drugs last year, a record number, the Trump administration said Friday. ...
Posted by Michael Wonder on 24 Jan 2018
Characteristics of interim publications of randomised clinical trials and comparison with final publications
23 January 2018 - Publication of interim results of randomised trials can be consequential, potentially undermining trial integrity by unblinding or ...
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 ...
Posted by Michael Wonder on 23 Jan 2018
Human medicines: highlights of 2017
23 January 2018 - 92 medicines recommended for approval, including 35 with a new active substance. ...
Posted by Michael Wonder on 22 Jan 2018
Registration of new chemical entities in Australia
22 January 2018 - New year leads to improved transparency on regulatory dossier timelines; submission dates yet to be disclosed. ...
Posted by Michael Wonder on 20 Jan 2018
The FDA should shine more light on drug rejections
19 January 2018 - The status quo helps companies doll up failures, hurting investors and public health. ...
Posted by Michael Wonder on 17 Jan 2018
Gottlieb changes course on FDA publication of rejection letters
16 January 2018 - Before Scott Gottlieb was in charge of the FDA, he called on the agency to publicly ...
Posted by Michael Wonder on 29 Nov 2017
Is the FDA withholding data about a controversial drug to protect its manufacturer?
29 November 2017 - In the case of Sarepta, it sure looks that way. ...
Posted by Michael Wonder on 20 Nov 2017
TGA business plan 2017-18
20 November 2017 - The business plan sets out the agency's product regulation, regulatory reform and international engagement agenda for 2017-18 ...