Welcome to Insider issue #34.
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In our second analysis issue of 2025, Leon Chagal examines the FDA's finalized guidance on standardized formats for electronic submissions of bioresearch monitoring (BIMO) data for drugs and biologics. He provides a comprehensive breakdown of submission requirements and practical strategies for effectively implementing these standards.
Our MedTech section features Kittu Rao's detailed analysis of the FDA's guidance on reporting medical device shortages. The piece offers crucial insights into new notification requirements and their operational impacts on manufacturers. It includes real-world examples and actionable recommendations for developing robust reporting systems.
Finally, Diamond Dent-Mitchell examines five recent FDA warning letters to medical device manufacturers, focusing on quality system and CAPA deficiencies. This detailed breakdown reveals common compliance gaps while providing practical guidance for strengthening quality systems.
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