All Scientific advice procedures articles
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Industry newsEMA establishes new standard procedure for high-risk medical devices
The European Medicines Agency (EMA) has established a standard procedure for manufacturers of high-risk Class III and Class IIb medical devices to request scientific advice.
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JournalPS1: Resolving specific development hurdles via scientific advice
Regulatory Rapporteur November 2024 | Volume 21 | No.10 Leaders: Sandra Lourenço, Director of Regulatory Affairs, Arriello, Ireland Andrea Laslop, Head of Scientific Office, Austrian Agency for Health and Food Safety, Austria Speakers: Peggy Sarah, the ...