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Glossary

Direct Healthcare Professional Communication (DHPC)

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A communication intervention by which important information is delivered directly to individual healthcare professionals by a marketing authorization holder or by a competent authority, to inform them of the need to take certain actions or adapt their practices in relation to a medicinal product.

Other glossary definitions

C

Common Technical Document (CTD)

The structure and format of applications to be submitted to regulatory authorities in the USA,…

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I

Investigational Device Exemption (IDE)

Approval of an Investigational Device Exemption (IDE) submission must occur by the FDA before a…

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