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. ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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10 July 2019 - Today, the U.S. FDA announced a draft guidance, Harmonizing Compendial Standards With Drug Application Approval Using the ...

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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 ...

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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 ...

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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 ...

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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.  ...

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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, ...

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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 ...

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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 ...

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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. ...

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