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An investigational device exemption (IDE) allows an investigational device (i.e. a device that is the subject of a clinical study [1]) to be used in order to collect safety and effectiveness data required to support a premarket approval (PMA) application or a premarket notification [510(k)] submission to Food and Drug Administration (FDA). [2]
Houston, TX, Dec. 10, 2024 (GLOBE NEWSWIRE) -- The US Food and Drug Administration (FDA) has granted EndoQuest Robotics, Inc., a privately-held pioneer in the development of flexible endoluminal robotic technologies, an Investigational Device Exemption (IDE) for its pivotal colorectal clinical study, Prospective Assessment of a Robotic-Assisted Device in Gastrointestinal Medicine (PARADIGM).
Expanded access or compassionate use is the use of an unapproved drug or medical device under special forms of investigational new drug applications (IND) or IDE application for devices, outside of a clinical trial, by people with serious or life-threatening conditions who do not meet the enrollment criteria for the clinical trial in progress.
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.
Cytori Provides Update in 510(k) Appeal Decision SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics (NAS: CYTX) today announced that the United States Court of Appeals for the District of Columbia ...
In drug development and medical device development [1] the Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product ("IP" or "study drug") obtained during a drug trial. The IB is a document of critical importance throughout the drug development process and is updated with new ...
Richland, WA, Feb. 04, 2025 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL) is pleased to report that the first five patients demonstrated the safety of RadioGel Precision Radionuclide Therapy TM by satisfying the criteria in the Clinical Study Plan, including confirmation via PET imaging that the Y-90 remained at the point of injection and no adverse events reported by any of the initial five ...
To legally test the drug on human subjects in the United States, the maker must first obtain an Investigational New Drug (IND) designation from FDA. [5] This application is based on nonclinical data, typically from a combination of in vivo and in vitro laboratory safety studies, that shows the drug is safe enough to test in humans. [5]