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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.
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]
On Tuesday, the U.S. Food and Drug Administration (FDA) placed a clinical hold on Atara Biotherapeutics, Inc.’s (NASDAQ:ATRA) active Investigational New Drug (IND) applications.
Fermentation Suite. In 2006, Intralytix was the first company in the world to receive FDA/USDA approval for a bacteriophage-based food safety product, ListShield. [1]That same year, Intralytix was also the first company in the world to successfully assemble a Master Drug File (MDF) application with the FDA, and to manufacture and supply its phage product for the first-ever in the US human ...
Cambridge, MA USA, Sept. 03, 2024 (GLOBE NEWSWIRE) -- BlueRock Therapeutics LP, a clinical stage cell therapy company and wholly owned, independently operated subsidiary of Bayer AG, today announced the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for OpCT-001, an investigational induced pluripotent stem cell (iPSC)-derived cell ...
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage. See the list of FDA-approved therapeutic monoclonal antibodies in the monoclonal antibody therapy page.