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Glossary

International Birth Date (IBD)

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The date of the first marketing authorization for any product containing the active substance granted to any company in any country in the world.

Other glossary definitions

P

Protocol Assistance (PA)

Protocol assistance is the special form of scientific advice available for companies developing designated orphan…

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I

Integrated summary of Safety (ISS)

Comprehensive integrated analysis of the effectiveness of a study drug, recommended to be submitted to…

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