Good Lay Summary Practice
On 4 October 2021 the European Commission added guidance to Chapter V of EudraLex Volume 10.
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Content and Format of Substantial Equivalence Reports; FDA Actions on Substantial Equivalence Reports
On 5 October 2021 the FDA published the final rule on the content and format of substantial equivalence reports.
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European Union Clinical Trials Information System CTIS: Go-live Planning
On 8 October 2021 the EMA published the summary of key areas in preparation for the CTIS implementation.
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Medical Device De Novo Classification Process
On 5 October 2021 the FDA published the final rule on the medical device De Novo classification process.
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More Than 100 Applications Lost Equivalence Rating Thanks to Allegedly Falsified Data at Two CROs
On 11 October 2021 Informa.com published analysis on the impact of data integrity issues.
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