Providing Regulatory Submissions for Medical Devices in Electronic Format — Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act
On 15 July 2020 the FDA issued the final guidance for industry and FDA staff.
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Patient-Focused Drug Development: Collecting Comprehensive and Representative Input
On 16 June 2020 the FDA announced the availability of the final guidance for industry, FDA staff, and other stakeholders.
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Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing
On 19 June 2020 the FDA announced the availability of the final guidance for industry.
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Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency
On 17 June 2020 the FDA announced the availability of the final guidance for industry.
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Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices - Questions and Answers
On 22 June 2020 the FDA published the final guidance on the Q&A for industry and FDA staff.
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