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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

C

Comparability Protocol

A comprehensive, prospectively written plan for assessing the effect of a proposed CMC post-approval change…

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A

Antimicrobial Resistance (AMR)

Antimicrobial Resistance (AMR) occurs when bacteria, viruses, fungi and parasites no longer respond to antimicrobial…

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