Quick Interactive Guide to IRIS Registration Process
On 25 August 2020 the EMA announced the availability of the quick interactive guidance.
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Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential Questions and Answers
On 27 August 2020 the ICH E14/S7B Implementation Working Group (IWG) announced the availability of the ICH E14/S7B Draft Q&As.
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MHRA Regulatory Flexibilities Resulting from Coronavirus (COVID-19)
On 4 August 2020 the UK MHRA updated the guidance for industry on flexible approaches to regulations taken during the COVID-19 outbreak.
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Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation
On 28 August 2020 the FDA announced the availability of the draft guidance for industry and FDA staff, and other stakeholders.
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Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format
On 10 August 2020 the FDA announced the availability of the final guidance for industry.
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