Blog
RSS FeedPosted by Michael Wonder on 01 Apr 2020
Coronavirus Treatment Acceleration Program
1 April 2020 - FDA has created a special emergency program for possible therapies, the Coronavirus Treatment Acceleration Program. ...
Posted by Michael Wonder on 01 Apr 2020
COVID-19 update: FDA continues to accelerate development of novel therapies for COVID-19
31 March 2020 - As part of the Trump Administration’s all-hands-on-deck approach across public, academic and private sectors to combat the ...
Posted by Michael Wonder on 31 Mar 2020
Expedited COVID-19 medical device application process
31 March 2020 - The Therapeutic Goods Administration is currently undertaking an expedited assessment process for all medical devices associated with ...
Posted by Michael Wonder on 31 Mar 2020
Developing COVID-19 vaccines at pandemic speed
30 March 2020 - Rapid publication of a perspective co-authored by former head of Australian Department of Health. ...
Posted by Michael Wonder on 29 Mar 2020
Pharma’s future blockbusters laid up with coronavirus
27 March 2020 - Normally a haven during downturns, pharmaceuticals will see forthcoming products delayed as pandemic disrupts or delays clinical ...
Posted by Michael Wonder on 25 Mar 2020
Coronavirus drugs, vaccine are many months away, health experts say
24 March 2020 - Public- and private-sector medical officials cautioned that further study is needed to assess possible treatments pushed by ...
Posted by Michael Wonder on 18 Mar 2020
ICER indefinitely postpones public meetings for sickle cell disease and cystic fibrosis; expands other assessment timelines up to three months
18 March 2020 - Updated schedules are intended to enable participating clinical experts and patient advocates to focus on caring for ...
Posted by Michael Wonder on 17 Mar 2020
Atomoxetine – further delay in change of funded brand and open access
17 March 2020 - Due to manufacturing delays, PHARMAC has delayed the listing of Generic Partners brand atomoxetine by 2 ...
Posted by Michael Wonder on 15 Mar 2020
Brexit means coronavirus vaccine will be slower to reach the UK
15 March 2020 - And it will cost more here because of the UK pulling out of the European Medicines Agency ...
Posted by Michael Wonder on 12 Mar 2020
Acacia Pharma announces brief extension of FDA review period for NDA for Byfavo, an ultra-short acting and reversible anesthetic for procedural sedation
12 March 2020 - Acacia Pharma announces that the US FDA has extended the review period for the new drug ...
Posted by Michael Wonder on 05 Mar 2020
Trevena announces FDA has set PDUFA date of 7 August 2020 for oliceridine
5 March 2020 - FDA considers NDA resubmission a complete Class 2 response. ...
Posted by Michael Wonder on 05 Mar 2020
FDA track: PDUFA Performance
5 March 2020 - The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Prescription Drug User ...
Posted by Michael Wonder on 27 Feb 2020
Zogenix announces FDA extension of review period for Fintepla in Dravet syndrome
27 February 2020 - Zogenix today announced that the U.S. FDA has extended the review period for the new drug application ...
Posted by Michael Wonder on 19 Feb 2020
Medical device application processing times
19 February 2020 - Australia's regulatory framework for therapeutic goods is undergoing a number of changes in response to the Review ...
Posted by Michael Wonder on 07 Feb 2020
Blueprint Medicines announces PDUFA date extension for new drug application of avapritinib for the treatment of adults with fourth-line gastro-intestinal stromal tumour
6 February 2020 - PDUFA action date extended by three months to 14 May 2020. ...