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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Updated financial estimates workbook

28 April 2020 - An updated version of the Utilisation and Cost Model workbook is now available to support a PBAC ...

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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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NICE publishes first rapid COVID-19 guidelines

21 March 2020 - New guidelines cover the management of patients in critical care, the management of patients who are having ...

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Coronavirus (COVID-19) update: FDA issues guidance for conducting clinical trials

18 March 2020 - The U.S. Food and Drug Administration today issued a guidance for industry, investigators and institutional review ...

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FDA finalises guidance for industry on applications for drugs with inadequate generic competition

13 March 2020 - Today, the U.S. FDA finalised guidance for industry, “Competitive Generic Therapies” (CGTs), which describes the process that ...

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FDA proposes broad approach for conducting safety trials for type 2 diabetes medications

9 March 2020 - The U.S. FDA today issued a new draft guidance, “Type 2 Diabetes Mellitus: Evaluating the Safety ...

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Reformatting Product Information: frequently asked questions

6 March 2020 - A new product information form was approved on 8 November 2017, with a commencement date of ...

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