FDA
FDA finalizes guidance on new dietary ingredient notifications
The final guidance addresses frequently asked questions and recommends identity and safety information for notifications covering new dietary ingredients and supplements containing them.
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EMA considers revising its hypertension clinical investigation guideline
EMA opened consultation on a concept paper addressing the need to revise its guideline for clinical investigation of medicinal products used to treat hypertension.
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EMA consults on data quality for adverse drug reaction reports
The agency released a draft framework applying EU medicines data quality principles to the collection, management and submission of adverse drug reaction reports.
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EMA adopts principles for assessing SmPC section 5.1
EMA adopted methodological principles for assessing section 5.1 of the Summary of Product Characteristics.
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EMA opens consultation on confirmatory platform trials
The agency published a draft reflection paper on methodological aspects of confirmatory platform trials for consultation.
Read the official sourceWhy this matters
These updates span evidence generation, safety data quality, labeling assessment and dietary ingredient submissions. Regulatory teams should review the final FDA recommendations and adopted EMA principles, while tracking the three open EMA consultations for potential changes to future expectations.
Scott Morvay
Founder, Gulfstream Intelligence
This brief provides general regulatory news and educational information. It is not legal or regulatory advice.