FDA may not always require post-approval trials to be enrolled before accelerated approvals

30 January 2023 - A FDa official on Monday gave more clues for how the agency plans to wield new authority ...

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The 4 biggest questions about the FDA’s forthcoming changes to accelerated approvals

25 January 2023 - Congress just boosted the FDA’s authority over the post-market clinical trials that are a condition of ...

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FDA’s breakthrough program: faster drug OKs without sacrificing safety

18 January 2023 - A FDA program markedly cut the time and cost of bringing to market new drugs, without ...

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Prescription drug policy, 2022 and 2023: the year in review and the year ahead

9 January 2023 - This past year featured many significant developments in the prescription drug policy area, most notably the passage ...

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FDA cancer chief wants quicker ways to pull failed drugs

17 November 2022 - Makena highlights need to make system more nimble. ...

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Gottlieb, McClellan push for FDA regulatory reforms

14 October 2022 - The decision by law makers to drop regulatory reforms of dietary supplements, cosmetics and diagnostic tests from ...

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COVID-19 vaccine procurement review says rapid access to vaccines and treatments key to on-going protection of Australians

27 September 2022 - Medicines Australia welcomes the independent review of Australia’s COVID-19 vaccine and treatment procurements by Professor Jane ...

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Halton review into vaccine and treatment procurement

27 September 2022 - Professor Jane Halton AO has handed to Government her independent review of Australia’s COVID-19 vaccine and treatment ...

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The on- and off-ramps of oncology accelerated approval

21 September 2022 - To address ongoing concerns about the implementation of the FDA’s accelerated approval pathway in oncology, a ...

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Accelerated approval of cancer drugs: no economic reward for drug makers that conduct confirmatory trials

17 August 2022 - The FDA uses expedited approval of drugs to speed the development and assessment of drugs that address ...

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Review into COVID-19 vaccine and treatment purchases

30 June 2022 - The Australian Government is undertaking an independent review of Australia’s vaccine and treatment procurements, led by former ...

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Expediency versus efficacy: re-examining the FDA’s accelerated drug approval process

23 June 2022 - It was precisely 30 years ago, in 1992, that the FDA established the accelerated approval program ...

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Accelerated approval: unfulfilled promises for FDA’s expedited review program

27 May 2022 - As practicing physicians, approval by the U.S. FDA reassures us that the treatments we prescribe our patients ...

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Congress moves toward reforming FDA accelerated approvals, but with pharma friendly concessions

4 May 2022 - House lawmakers are moving a little closer toward cracking down on drugmakers that game the FDA’s ...

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It’s time to fix the FDA by breaking it up

11 April 2022 - A new investigation about the agency’s failures underscores the need for a separate agency to keep our ...

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