ICH has published for consultation the E2D(R1) draft Guideline, which covers: “Post-Approval Safety Data: Definitions and Standards for Management and Reporting of individual Case Safety Reports”.
The FDA is calling for comments on a new draft guidance entitled: “Use of Data Monitoring Committees in Clinical Trials”, which is intended to replace the guidance from March 2006.
The FDA has also published for comments a new draft guidance entitled: “Key Information and Facilitating Understanding in Informed Consent”.
The EMA has launched the two EMA-HMA catalogues of RWD (Real-World Data) sources and RWD studies, which replace the ENCePP Resources Database and EU PAS Register.
The first “mega” client account (nearly 500 users) was onboarded to the new Reading Platform in February and the total number of user accounts is now greater than 900.
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