Establishing an intelligent clinical development program pathway from the start is vital for clarity around the complex processes required to achieve product registration.
The Drug Development Plan (DDP) plan informs every part of the journey from budgeting, timelines, clinical phases, research partners, research locations, regulator engagement, staff hires and much more.
Ultimately a DDP describes the steps that are required to generate the evidence to support marketing authorisation and reimbursement.
An external DDP advisory team needs to be expert across all regulatory affairs and product development including manufacturing, toxicology and medical writing, and planning should start from the pre-clinical development phase.
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March 26, 2021 at 02:00PM
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Orphazyme's pipeline-in-a-product whiffs in second trial, though FDA decision still awaits - Endpoints News
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