New FDA Guidance for REMS revisions
The FDA has issued a new final guidance entitled “Risk Evaluation and Mitigation Strategies (REMS): Modifications and Revisions”, which updates the 2015 guidance.
FDA Guidance for Combination Products
The FDA has published the Final Guidance to support compliance with the final rule describing postmarketing safety reporting requirements for combination products, which the Agency will start enforcing from 31-Jul-2020.
WEB-RADR and Social Media
The WEB-RADR Team has published a new article in the Drug Safety journal, which provides a range of recommendations for the use of social media in statistical Signal Detection.
MHRA GPvP Inspections Symposium
The MHRA has announced that the next GPvP Inspectorate will be hosting its next symposium on 11-Feb-2020 in London, and is inviting stakeholders to share their thoughts on possible topics.
New SAHPRA SAE Reporting guidance
The South African Health Products Regulatory Authority (SAHPRA) has issued a revised version of the guideline covering Safety Reporting during Clinical Trials.
Hot topics are taken from Safety Observer Lite 159, Sep 2019