Multiple Function Device Products: Policy and Considerations
On 29 July 2020 the FDA issued the final guidance for industry and FDA staff.
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MHRA Updated Guidance for the Notification of Serious Breaches of GCP or the Trial Protocol
On 31 July 2020 the UK MHRA announced the availability of the updated guidance.
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Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking
On 1 July 2020 the FDA issued the immediately in effect guidance for industry and FDA staff.
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Global Regulatory Workshop on COVID-19 Therapeutics #2: Agreement on Acceptable Endpoints for Clinical Trials
On 31 July 2020 the international regulators published a report on the acceptability of various primary endpoints in the clinical trials conducted for the development of treatments for COVID-19.
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Updated FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency
On 2 July 2020 the FDA updated the final guidance for industry, investigators and IRBs.
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