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.
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A complete clinical development plan for Oxabact has been presented in Protocol Assistance and End-of-Phase II meetings with EMA and FDA respectively.
Bristol-Myers Squibb and Nektar have agreed to a joint clinical development plan to evaluate NKTR-214 with Opdivo and Opdivo plus Yervoy in registration-enabling clinical trials in more than 20 indications in 9 tumor types including melanoma, renal cell carcinoma, non-small cell lung cancer, bladder and triple negative breast cancer.
Merck plans to discuss these results and the Phase 3 clinical development plan for MK-7264 with regulatory agencies later this year.
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).
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.
We are excited to begin the HCC trial, which constitutes another milestone in the G-202 clinical development plan," said Craig Dionne, PhD, GenSpera CEO and President.
Last week, Photocure presented a new Cevira medical device, treatment procedure and clinical development plan to the US Food and Drug Administration (FDA).
With the feasibility study under way, we continue to move forward in accordance with our clinical development plan to bring antineoplastons therapy to market for the treatment of a disease with such a poor prognosis," said institute president Stanislaw R.
MultiCell has scheduled a meeting with the MHRA for December 1, 2006, to present the company's clinical development plan for the Phase IIb of MCT-125.
M2 PHARMA-July 28, 2017-FDA Indicates Willingness to Accept Capricor's Proposed Clinical Development Plan for Intravenous CAP-1002 for Duchenne Muscular Dystrophy
Tiziana Life Sciences plc (AIM: TILS, the "Company"), a clinical stage biotechnology company focused on targeted drugs to treat diseases in oncology and immunology, today announced its plan for further development of foralumab, the company's fully human anti-CD3 antibody, along with the addition of two key members: Professors Kevan Herold, MD and Howard Weiner, MD who will be joining its Scientific Advisory Board and focusing on pioneering a unique clinical development plan for foralumab.
Our team of experienced development scientists formulate and produce required quantities of clinical trial materials for all stages of your molecule's clinical development plan.
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