Blog
RSS FeedPosted 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10 July 2019 - Today, the U.S. FDA announced a draft guidance, Harmonizing Compendial Standards With Drug Application Approval Using the ...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 ...
Posted by Michael Wonder on 22 Jun 2019
Delayed patient access to innovative medical technologies in South Korea: a lead-time analysis of reimbursement coverage determinations
20 June 2019 - Timely access to innovative medical technologies driven by accelerated patient access pathways can substantially improve the health ...
Posted by Michael Wonder on 22 Jun 2019
Should the FDA speed up or slow down approval of new cancer drugs?
21 June 2019 - Earlier this month, the FDA announced the creation of Project Facilitate. ...
Posted by Michael Wonder on 19 Jun 2019
Game-changing cancer drugs which can attack all tumours will be fast-tracked by NHS
19 June 2019 - Game-changing cancer drugs which can attack all types of tumour will be fast-tracked by the NHS, ...
Posted by Michael Wonder on 19 Jun 2019
Atomoxetine – delay in change of funded brand and open access
19 June 2019 - PHARMAC is advising all interested parties that there will be a delay in the listing of ...
Posted by Michael Wonder on 17 Jun 2019
Updated PBAC Calendar and publication of Stage 1 PBS Process Improvements – Procedure Guidance and supporting documents
17 June 2019 - The Department of Health and Medicines Australia have been working since late 2017 to deliver on ...
Posted by Michael Wonder on 04 Jun 2019
US FDA review for Scenesse extended by three months
3 June 2019 - The FDA sets new goal date of 6 October 2019 to complete review and issue risk-benefit decision. ...