TGA - 2019 in review

14 January 2020 - According to the TGA, it approved 34 new chemical entities in 2019. ...

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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 ...

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FDA – 2019 in review

8 January 2020 - Analysis of NDA approval timelines for 2019. ...

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FDA’s deadline problem?

3 January 2020 - Rush to meet end-of-year drug-approval deadlines leads to more adverse effects, new study shows. ...

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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 ...

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FDA approving drugs at breakneck speed, raising alarm

7 December 2019 - Breakthrough products beating deadlines by weeks, even months. ...

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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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