Search results
Results from the WOW.Com Content Network
Decentralized Trials & Research Alliance (DTRA) is a 501(c)(3) nonprofit organization in the United States that works to accelerate the adoption of patient-focused, decentralized trials and research within life sciences and healthcare through education and research. DTRA works to make research participation accessible to everyone, enabled by ...
Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery.It includes preclinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may ...
The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.
The Biotechnology Innovation Organization (BIO) is the largest advocacy association in the world representing the biotechnology industry. [1] [2] [3] It was founded in 1993 as the Biotechnology Industry Organization from a merger of the Industrial Biotechnology Association (IBA) and the Association of Biotechnology Companies (ABC), [4] and changed its name to the Biotechnology Innovation ...
Since the 1962 Kefauver–Harris Amendment, new drugs are statutorily required to demonstrate both safety and effectiveness through substantial evidence for approval. The amendment defines substantial evidence as "evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the ...
Academic clinical trials – clinical trials run at academic centers (e.g., medical schools, academic hospitals, and universities) Clinical trials unit – biomedical research units dedicated to conducting clinical trials; Epidemiology – the study of factors affecting the health and illness of populations
Open-label phase 2 clinical trial in CDD with cannabidiol (Epidiolex) [38] New Phase 2 clinical trial in CDD with fenfluramine [23] Gene therapy Ultragenyx has announced a clinical development program for AAV-based gene replacement therapy for CDD. This program is currently classified by the company as in the “pre-clinical” stage. [39]
The stated goal of NCATS is to promote research in both existing and new areas of medicine and science, in order to promote public health and to overcome high failure rates in clinical trials. [ 9 ] [ 10 ] To accomplish this, NCATS supports 31 programs and initiatives that relate to translational research and improving the speed of therapeutic ...