Blog

Sciformix is committed to sharing ideas and insights with the life science industry and support the development and commercialization of safe and effective products. Our employees and partners share their knowledge and thought leadership.

More Oversight Of AEDs Proposed By FDA


Susan Najjar

A proposal to improve the quality and reliability of automated external defibrillators (AEDs) has been issued by the U.S. Food and Drug Administration.  Manufacturers of these life-saving devices will need to send in pre-market approval (PMA) applications if the proposed order is...

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EU Medicines Agency updates procedural guidance in line with new pharmacovigilance legislation


Susan Najjar

The European Medicines Agency has revised its procedural guidance for pharmaceutical companies to include the latest information related to the new pharmacovigilance legislation. The guidance for applicants covers pre- and post-authorisation procedures. There are also specific sections for generic, hybrid and biosimilar...

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