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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.
The journal was established by Current Drugs in 1992, under the title Current Opinion in Investigational Drugs. In 1994, the journal was acquired by Ashley Publications, who published it until 2015, when it was acquired by Taylor & Francis. The current Editor-in-Chief is Dr. Naim Alkhouri (Texas Liver Institute, San Antonio, Texas, USA).
NV-5138 also known as SPN-820 is an investigational new drug that is being evaluated by Navitor Pharmaceuticals and Supernus Pharmaceuticals [2] for the treatment of major depressive disorder (MDD). [3] [1] [4] [5]
MALVERN, Pa., Jan. 27, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that the U.S. Food and Drug Administration (FDA) has reviewed the Company’s ...
FDA: Good Review Practice: Clinical Review of Investigational New Drug Applications. [2] This good review practice (GRP) document was prepared to assist FDA clinical review staff in reviewing clinical submissions to an investigational new drug application (IND) from the pre-IND phase to the time of the pre-new drug application/biologics license ...
PEMGARDA (pemivibart) injection (4500 mg), for intravenous use is an investigational mAb that has not been approved, but has been authorized for emergency use by the U.S. FDA under an EUA for the pre-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents (12 years of age and older weighing at least 40 kg) who have moderate-to ...
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]
Current Opinion in Drug Discovery & Development (ISSN 1367-6733) Current Opinion in Investigational Drugs (ISSN 0967-8298), established in 1992 continued as Expert Opinion on Investigational Drugs in 1994; Current Opinion in Investigational Drugs (ISSN 1472-4472), established in 2000, formed by the merger of