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In United States pharmaceutical regulatory practice, a Complete Response Letter (CRL), or more rarely, a 314.110 letter, is a regulatory action by the Food and Drug Administration in response to a New Drug Application, Amended New Drug Application or Biologics License Application, indicating that the application will not be approved in its present form. [1]
Charles River Laboratories International, Inc. is an American pharmaceutical company specializing in a variety of preclinical and clinical laboratory, gene therapy and cell therapy services for the pharmaceutical, medical device and biotechnology industries. [2]
Fladrafinil (developmental code name CRL-40,941), also known as fluorafinil or as bisfluoroadrafinil, is a wakefulness-promoting agent related to modafinil that was never marketed. [ 1 ] [ 2 ] [ 3 ] It is sold online and used non-medically as a nootropic (cognitive enhancer).
Liberty Medical Supply, Inc. ("Liberty Medical") is an American home delivery service that sells diabetes testing supplies, prescription drugs, urology supplies, and ostomy supplies directly to consumers. [1] The company was a subsidiary of Medco Health Solutions, Inc., which purchased Liberty Medical and its parent company, PolyMedica, in 2007 ...
Flmodafinil (developmental code names CRL-40,940, NLS-4, JBG01-41), also known as bisfluoromodafinil and lauflumide, is a wakefulness-promoting agent related to modafinil which has been developed for treatment of a variety of different medical conditions.
Reagent testing is one of the processes used to identify substances contained within a pill, usually illicit substances. With the increased prevalence of drugs being available in their pure forms, the terms "drug checking" or "pill testing" [1] may also be used, although these terms usually refer to testing with a wider variety of techniques covered by drug checking.