Clinical Pharmacology and Pharmacokinetics: Questions and Answers
On 25 May 2020 the EMA updated the Q&A document on clinical pharmacology and pharmacokinetics.
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Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications — Questions and Answers
On 26 May 2020 the FDA published this Q&A Guidance for Industry.
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FDA Provides Free Method to Obtain Informed Consent Electronically for Eligible Clinical Trials During the COVID-19 Public Health Emergency
On 29 May 2020 the FDA announced the availability of the free COVID MyStudies Application (App) for obtaining informed consent remotely.
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Qualification of digital technology-based methodologies to support approval of medicinal products: Questions and Answers
On 27 May 2020 the EMA published the Q&A document on qualification of digital technologies.
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MHRA GCP Inspections Metrics Report: 1st April 2017 – 31st March 2018
On 4 May 2020 the UK MHRA issued the GCP inspection metrics report covering the period 1st April 2017 to 31st March 2018.
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