FDA initiatives to accelerate the development of COVID-19 therapeutics

18 August 2020 - More than 750,000 deaths have occurred worldwide as a result of the novel coronavirus as of ...

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Acute myeloid leukaemia: developing drugs and biological products for treatment

17 August 2020 - The purpose of this guidance is to assist sponsors in the clinical development of drugs and biological ...

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MSAC Guidelines review

17 August 2020 - The Department of Health has commenced a review of the MSAC technical guidelines to ensure assessment ...

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Principles for deliberative processes in health technology assessment

4 August 2020 - Deliberative processes are a well-established part of health technology assessment programs in a number of high- and ...

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International regulators provide guiding principles for COVID-19 clinical trials

1 July 2020 - EMA has endorsed a joint statement on prioritisation of COVID-19 clinical trials published by the International ...

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FDA takes action to help facilitate timely development of safe, effective COVID-19 vaccines

30 June 2020 - Today, the U.S. FDA took important action to help facilitate the timely development of safe and effective ...

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Procedure Guidance for standardised redactions to PBAC Public Summary Documents

30 April 2020 - The PBAC has indicated its preference for greater transparency to be introduced in PSDs through a ...

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NICE publishes two new COVID-19 guidelines

23 April 2020 - NICE has published 2 new rapid COVID-19 guidelines on the care of patients with suspected and confirmed ...

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New U.S. treatment guidelines for COVID-19 don’t see much progress

21 April 2020 - A panel of experts said there was insufficient evidence about many drugs that have been considered as ...

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Product specific guidances for chloroquine phosphate and hydroxychloroquine sulphate

13 April 2020 - The FDA plays a critical role in protecting the United States from threats including emerging infectious ...

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NICE publishes new COVID-19 guidelines on cystic fibrosis, chronic obstructive pulmonary disease and dermatological conditions treated with drugs affecting the immune response

9 April 2020 - NICE has today published 3 new rapid guidelines on the care of patients with suspected and confirmed ...

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NICE publishes new COVID-19 guidelines on severe asthma, pneumonia, rheumatological disorders and symptom management

4 April 2020 - They cover the management of patients with severe asthma, pneumonia, rheumatological autoimmune, inflammatory and metabolic bone disorders ...

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New WHO guide to help countries expand access to essential medicines

30 March 2020 - WHO’s new user guide for countries, ‘Selection of medicines at country level’, is based ...

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Updated Financial Estimates workbook and manual

30 March 2020 - An updated version of the Utilisation and Cost Model workbook and a user manual are now available ...

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Global regulators map out data requirements for phase 1 COVID-19 vaccine trials

24 March 2020 - Global regulators have published a report today presenting the outcomes of a workshop on COVID-19 vaccine ...

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