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Harmonised ICH M15 Guideline, General Principles for Model-informed Drug Development, Adopted
The ICH M15 Guideline, General Principles for Model-informed Drug Development, has been adopted (Step 4 of the ICH harmonisation process) and will now enter the implementation phase (Step 5). Prior to the development of the M15 Guideline, a lack of common standards...
Computer Software Assurance for Production and Quality Management System Software
FDA is issuing this guidance to provide recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality management system. This guidance: · Describes “computer software...
FDA CDER – 2025 New Drug Therapy Approvals: key takeaways
The FDA’s Center for Drug Evaluation and Research (CDER) has released its 15th annual New Drug Therapy Approvals report, offering a useful snapshot of the pace and direction of drug development in 2025. In 2025, CDER approved 46 new drugs never before approved or...
The MDSAP Audit Approach (MDSAP AU P0002.010) was just revised
Medical device/medtech regulatory updates this week: The MDSAP Audit Approach (MDSAP AU P0002.010) A few suggested next steps if you're impacted here: 1/ Audit your audit program. Your internal audit procedures and checklists likely reference QSR language and clause...
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