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Glossary

Briefing Book (or briefing materials)

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Documentation submitted to facilitate an Agency meeting, for example to request scientific advice in relation to a proposed drug development pathway.
It should contain company questions, justifications or company positions, and appropriate summary information.

Other glossary definitions

M

Medical Device Software

A “medical device software”, refers to a computer application that meets the legal definition of…

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M

MedWatch

MedWatch is the US Food and Drug Administration’s reporting program for product complaints. MedWatch MedWatch…

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