clinical development plan

clinical development plan

A document describing the clinical studies that must be performed during the development of a particular active substance, device, procedure or treatment strategy, typically with the intention of submitting the study data as part of an application to the FDA for marketing authorisation. The plan should indicate appropriate decision points and allow for trial modifications as knowledge accumulates.
Segen's Medical Dictionary. © 2012 Farlex, Inc. All rights reserved.
References in periodicals archive ?
'The positive feedback from the FDA regarding our clinical development plan to advance firibastat into Phase III trials in the United States represents a key milestone in the execution of our strategic plan as presented in April 2018.
- French clinical-stage biopharmaceutical company Sensorion (PAR: ALSEN) (FR0012596468 ALSEN) has received the Investigational New Drug clearance from the US Food and Drug Administration to proceed with SENS-401, based on preclinical data and clinical development plan, the company said.
Following the acquisition and having received input from the US FDA on its clinical development plan, Anji plans to initiate a pivotal Phase 3 study in patients with chronic kidney disease (Stage 3b/4) later this year.
"The clinical development plan for HepaStem is going to expand into the U.S.
NORDIC BUSINESS REPORT-September 7, 2018-NeuroVive announces positive US FDA's feedback for NeuroSTAT clinical development plan for TBI
Based on these promising results, Nanobiotix is currently establishing a clinical development plan, potentially in EU and USA, which could lead to the registration of NBTXR3 for use in this indication.
As part of the IADP offering Quintiles advises on considerations for an asset's value proposition, Target Product Profile (TPP), regulatory plan, and a Clinical Development Plan (CDP).The IADP also includes market access planning evidence generation plan, commercial launch plan, lifecycle management and real-world evidence risk management plans.
"We are pleased to provide physicians and patients with an important new option to treat HIV; atazanavir with cobicistat delivers sustained efficacy and safety through 48 weeks, as demonstrated through its rigorous clinical development plan, including a head-to-head Phase III trial," commented Murdo Gordon, head of worldwide markets for Bristol-Myers Squibb.
Maintaining control over the scientific design of the clinical development plan, as well as driving the interpretation of results, is key to many sourcing decisions.
National regulatory agencies can be in charge of this approach with the sponsor by the time the clinical development plan is discussed.
CanChew Biotechnology targets research and execution of their clinical development plan and subsequently out licensing or marketing and sales of its patented technology.
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