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Clinical research is a branch of medical research ... or case studies of off label use are submitted to the FDA in support of an Investigational New Drug application. ...
Most drugs undergoing Phase III clinical trials can be marketed under FDA norms with proper recommendations and guidelines through a New Drug Application (NDA) containing all manufacturing, preclinical, and clinical data. In case of any adverse effects being reported anywhere, the drugs need to be recalled immediately from the market.
Translational medicine (often called translational science, of which it is a form) develops the clinical practice applications of the basic science aspects of the biomedical sciences; that is, it translates basic science to applied science in medical practice.
A clinical pathway is a multidisciplinary management tool based on evidence-based practice for a specific group of patients with a predictable clinical course, in which the different tasks (interventions) by the professionals involved in the patient care are defined, optimized and sequenced either by hour (ED), day (acute care) or visit (homecare).
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.
In the U.S., the FDA eventually released new draft guidance in July 2011 on "mobile medical applications," with members of the legal community such as Keith Barritt speculating it should be read to imply "as applicable to all software, since the test for determining whether a mobile application is a regulated mobile 'medical' application is the ...
In the 1970s and 1980s it was the most commonly used programming language for clinical applications. The MUMPS operating system was used to support MUMPS language specifications. As of 2004, a descendant of this system is being used in the United States Veterans Affairs hospital system.
In T1-translation, new laboratory discoveries are first translated to human application, which includes phase I & II clinical trials. In T2-translation, candidate health applications progress through clinical development to engender the evidence base for integration into clinical practice guidelines. This includes phase III clinical trials.