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Category: Regulatory Updates

December 8, 2020 Regulatory Updates

Regulatory Updates-November 2020

MHRA: Draft guidance on randomised controlled trials generating real-world evidence to support regulatory decisions Read more… Philippines FDA: Full implementation

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December 8, 2020 Regulatory Updates

Regulatory Updates-October 2020

Swissmedic: Changeover to electronic submission of notifications of major changes: 1 November 2020 Read more… FDA: The Use of Physiologically

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October 13, 2020 September 2020

Regulatory Updates-September 2020

FDA: Information about Nitrosamine Impurities in Medications Read More.. WHO: Corticosteroids for Covid-19 Read More.. MHRA post-transition period information –

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September 4, 2020 August 2020 / Regulatory Updates / Uncategorized

Regulatory Updates-August 2020

FDA: Purple Book, lists of licensed biological products with reference product exclusivity and bio similarity or interchangeability evaluations Read More…

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August 4, 2020 July 2020 / Regulatory Updates

Regulatory Updates-July 2020

EMA: Questions and answers on regulatory expectations for medicinal products for human use during the covid-19 pandemic Read More… Swiss

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