Why FDA’s issuance of EUAs are not ‘approvals’ and why that matters

3 April 2020 - You may have read that some drugs are now “approved” to treat COVID-19, or as the ...

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Swiss Government expands powers to force firms to make supplies to fight COVID-19

3 April 2020 - The Swiss government on Friday boosted its powers to order companies to raise production of critical ...

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EMA provides recommendations on compassionate use of remdesivir for COVID-19

3 April 2020 - During an extraordinary virtual meeting held on 2 April 2020, EMA’s CHMP gave recommendations on how ...

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International regulators discuss available knowledge supporting COVID-19 medicine development

3 April 2020 - On 2 April, regulators from around the world joined the second workshop on COVID-19 organised by ...

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Biosimilars could disappear if the Supreme Court overturns the ACA

1 April 2020 - With the sense of urgency rightly focused on slowing or stopping the spread of COVID-19, it ...

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EMA urges caution on malaria drugs' use for COVID-19 in absence of evidence

1 April 2020 - The European Union's drug regulator warned on Wednesday that two older malaria drugs being tested against ...

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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: chloroquine and hydroxychloroquine only to be used in clinical trials or emergency use programmes

1 April 2020 - Chloroquine and hydroxychloroquine, two medicines currently authorised for malaria and certain autoimmune diseases, are being investigated ...

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Regulatory information - 1.6% increase in fees from 1 April 2020

1 April 2020 - General, non-pharmacovigilance fees payable to EMA by applicants and marketing-authorisation holders are increasing by 1.6% on ...

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Authorised nurse practitioners now eligible to prescribe certain Highly Specialised Drugs

1 April 2020 - From 1 April 2020, authorised nurse practitioners can prescribe hepatitis B, hepatitis C and HIV medicines ...

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Expanded access as a source of real‐world data: an overview of FDA and EMA approvals

22 March 2020 - The authors set out to identify, characterise, and compare all FDA and EMA approvals that included real‐world ...

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1 April 2020 price disclosure confirmed prices

31 March 2020 - Confirmed 1 April 2020 prices resulting from the 2020 April cycle of price disclosure have been published ...

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FDA on signing of the COVID-19 Emergency Relief Bill, including landmark over-the-counter drug reform and user fee legislation

30 March 2020 - On Friday, the President signed into law a $2 trillion emergency relief bill that will continue ...

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EMA to issue electronic certificates for medicines

30 March 2020 - EMA has implemented a new system to issue electronic certificates for human and veterinary medicines.  ...

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FDA announces funding opportunity to explore the use of real-world data to generate real-world evidence in regulatory decision making

25 March 2020 - The U.S. Food and Drug Administration is announcing a funding opportunity for projects to support the ...

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