Regulatory Blog

The FDA has issued two draft guidances in September 2026 covering important aspects of medical device regulatory submissions. One focuses on premarket submissions for robotically-assisted surgical devices (RASDs), while the other provides recommendations for the electronic submission of Premarket Approval (PMA) applications using the eSTAR template. These guidances highlight FDA's focus on structured technical evidence, software and cybersecurity considerations, clinical and

ICH M13B Guideline: Additional Strengths Biowaiver for Immediate-Release Solid Oral Dosage Forms The European Medicines Agency (EMA) has adopted the ICH M13B Guideline on Bioequivalence for Immediate-Release Solid Oral Dosage Forms – Additional Strengths Biowaiver, together with a related Questions and Answers (Q&A) document. The guideline provides recommendations for obtaining a biowaiver for one or more additional strengths when in vivo pharmacokinetic bioequivalence or eff

The European Medicines Agency (EMA) has published two complementary guidance documents explaining the new CTIS Safety Module for Annual Safety Reports (ASRs). Together, they describe the end-to-end process for ASR submission, assessment, safety issue management and finalisation. Sponsor Guidance: New Safety Module on the Annual Safety Report The Sponsor Guidance explains how sponsors will prepare, submit and manage Annual Safety Reports through the new Safety Module. Transiti