New legislation to support medicine substitutions

5 March 2021 - New legislation has been passed to allow pharmacists to substitute a different medicine when a patient's ...

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TGA adopts Access Consortium guidance for fast-tracking authorisations of modified COVID-19 vaccines for variant

5 March 2021 - TGA has adopted guidance developed by the Access Consortium - a coalition of regulatory authorities from ...

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FDA releases a new plan to bring its data skills up to speed

4 March 2021 - When Ram Iyer started his new job at the Food and Drug Administration in 2020, he ...

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Paying for prescription drugs in the new administration

2 March 2021 - In a national survey in January 2020 involving 1011 participants, the second-ranked domestic priority for members of ...

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Drug industry pushes FDA to solve growing inspection backlog

2 March 2021 - Inspections are a vital tool to ensure the safety of new drugs as well as medicines already ...

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EMA and Health Canada publish clinical data used to support their authorisations of the Moderna COVID-19 vaccine

2 March 2021 - Openness and transparency are key to building confidence in COVID-19 vaccines. Today, EMA and Health Canada ...

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International cooperation to align approaches for regulation of COVID-19 vaccines and medicines

25 February 2021 - Regulators around the globe are committed to aligning their regulatory requirements and addressing knowledge gaps to facilitate ...

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Three steps can help companies speed FDA approval of new drugs

24 February 2021 - Drug developers see FDA approval as a difficult uphill climb, requiring large investments of resources and ...

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TGA reviewing COVID-19 tests to rule out issues diagnosing variants

24 February 2021 - Adjunct Professor John Skerritt has tasked the nation’s medical regulator with ensuring COVID-19 tests are successfully ...

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TGA bans Pfizer, AstraZeneca brand mentions in COVID-19 vaccine advertising

24 February 2021 - Pharmacies, GPs and healthcare organisations will be banned from displaying advertisements identifying whether they are using ...

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FDA to allow Pfizer-BioNTech vaccine to be stored at higher temperatures

24 February 2021 - The U.S. FDA plans to approve Pfizer Inc and BioNTech SE’s request to store their COVID-19 ...

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Epilepsy drug deaths: Medsafe told PHARMAC it was 'not desirable' to switch brands

23 February 2021 - The medicines safety authority advised PHARMAC it was “not desirable” for patients to switch brands of ...

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Proposal leaves surgeons bound by private health

23 February 2021 - Australians paying thousands of dollars a year in health insurance could have their access to life-changing ...

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EMA publishes agenda for 22-25 February CHMP meeting

22 February 2021 - The EMA has published a draft agenda for this week's CHMP meeting. ...

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EMA plots earlier engagement with patient groups

19 February 2021 - The EMA on Friday announced it will pilot an early engagement program to bring patient and ...

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