Blog
RSS FeedPosted by Michael Wonder on 14 Jan 2020
TGA - 2019 in review
14 January 2020 - According to the TGA, it approved 34 new chemical entities in 2019. ...
Posted by Michael Wonder on 12 Jan 2020
Atomoxetine – further delay in change of funded brand and open access
10 January 2020 - PHARMAC is advising all interested parties that there is a further delay in the listing of ...
Posted by Michael Wonder on 08 Jan 2020
FDA – 2019 in review
8 January 2020 - Analysis of NDA approval timelines for 2019. ...
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 10 Dec 2019
Speeding access to new and innovative cancer treatments
8 December 2019 - An emerging measure for predicting cancer treatment outcomes could dramatically speed clinical trials and the approval of ...
Posted by Michael Wonder on 09 Dec 2019
FDA approving drugs at breakneck speed, raising alarm
7 December 2019 - Breakthrough products beating deadlines by weeks, even months. ...
Posted by Michael Wonder on 19 Oct 2019
Criticism won’t slow targeted cancer drug reviews: FDA official
18 October 2019 - FDA’s accelerated approval pathway has faced criticism it’s not really helping patients. ...
Posted by Michael Wonder on 15 Oct 2019
Health Minister Greg Hunt promises to speed up drug subsidy approvals
15 October 2019 - Health Minister Greg Hunt has promised to slash red tape from the process of approving new ...
Posted by Michael Wonder on 15 Oct 2019
Pharmaceutical Benefits Advisory Committee responds to criticism
15 October 2019 - Chair Andrew Wilson told newsGP suggestions of delayed approvals are nothing new and Australia has one of ...
Posted by Michael Wonder on 14 Oct 2019
PBS drug listings being delayed by bureaucracy, medicines lobby says
15 October 2019 - The head of the powerful medicines lobby says Australians are being forced to wait longer to ...
Posted by Michael Wonder on 14 Oct 2019
Flexion Therapeutics announces extended FDA review of supplemental new drug application for Zilretta
14 October 2019 - Flexion Therapeutics today announced that the U.S. FDA has informed the company it needs additional time ...
Posted by Michael Wonder on 01 Aug 2019
Fast track pathways for drug approvals: the Australian experience so far
1 August 2019 - In 2016, the Australian Government announced that the Therapeutic Goods Administration would establish two new pathways ...
Posted by Michael Wonder on 10 Jul 2019
FDA announces new efforts to expedite generic drug development and marketing to improve patient access to medicines
10 July 2019 - Today, the U.S. FDA announced a draft guidance, Harmonizing Compendial Standards With Drug Application Approval Using the ...
Posted by Michael Wonder on 01 Jul 2019
Delays a matter of life and death
1 July 2019 - The shocking news that Aussie cancer patients are facing long waits for essential medicines is cause for ...
Posted by Michael Wonder on 30 Jun 2019
Why it takes five years for life saving medicines to get funded
30 June 2019 - Cancer patients are waiting up to five years to access life-saving medicines as spending on the ...