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News »

EMA-FDA parallel scientific advice program has ‘limited’ uptake

Industry requests more information from FDA on dosage and administration labeling

Books »

Fundamentals of EU Regulatory Affairs, Ninth Edition

Quality Management Systems for Drugs and Devices (e-book)

Learning »

Ensure Your MDR Program is State of the Art (On-Demand)

SaMD Product Development: Addressing Challenges through Early Integration of Regulatory, Quality and Clinical Data Strategies (On-Demand)

Events »

Software as a Medical Device (SaMD) (June 2023)

Survivor: The FDA 510(k) Program Edition (April 2023)

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