Coronavirus Treatment Acceleration Program

1 April 2020 - FDA has created a special emergency program for possible therapies, the Coronavirus Treatment Acceleration Program.  ...

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COVID-19 update: FDA continues to accelerate development of novel therapies for COVID-19

31 March 2020 - As part of the Trump Administration’s all-hands-on-deck approach across public, academic and private sectors to combat the ...

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Expedited COVID-19 medical device application process

31 March 2020 - The Therapeutic Goods Administration is currently undertaking an expedited assessment process for all medical devices associated with ...

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Developing COVID-19 vaccines at pandemic speed

30 March 2020 - Rapid publication of a perspective co-authored by former head of Australian Department of Health. ...

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Pharma’s future blockbusters laid up with coronavirus

27 March 2020 - Normally a haven during downturns, pharmaceuticals will see forthcoming products delayed as pandemic disrupts or delays clinical ...

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Coronavirus drugs, vaccine are many months away, health experts say

24 March 2020 - Public- and private-sector medical officials cautioned that further study is needed to assess possible treatments pushed by ...

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ICER indefinitely postpones public meetings for sickle cell disease and cystic fibrosis; expands other assessment timelines up to three months

18 March 2020 - Updated schedules are intended to enable participating clinical experts and patient advocates to focus on caring for ...

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Atomoxetine – further delay in change of funded brand and open access

17 March 2020 - Due to manufacturing delays, PHARMAC has delayed the listing of Generic Partners brand atomoxetine by 2 ...

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Brexit means coronavirus vaccine will be slower to reach the UK

15 March 2020 - And it will cost more here because of the UK pulling out of the European Medicines Agency ...

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Acacia Pharma announces brief extension of FDA review period for NDA for Byfavo, an ultra-short acting and reversible anesthetic for procedural sedation

12 March 2020 - Acacia Pharma announces that the US FDA has extended the review period for the new drug ...

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Trevena announces FDA has set PDUFA date of 7 August 2020 for oliceridine

5 March 2020 - FDA considers NDA resubmission a complete Class 2 response. ...

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FDA track: PDUFA Performance

5 March 2020 - The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Prescription Drug User ...

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Zogenix announces FDA extension of review period for Fintepla in Dravet syndrome

27 February 2020 - Zogenix today announced that the U.S. FDA has extended the review period for the new drug application ...

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Medical device application processing times

19 February 2020 - Australia's regulatory framework for therapeutic goods is undergoing a number of changes in response to the Review ...

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Blueprint Medicines announces PDUFA date extension for new drug application of avapritinib for the treatment of adults with fourth-line gastro-intestinal stromal tumour

6 February 2020 - PDUFA action date extended by three months to 14 May 2020. ...

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