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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]
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).
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]
Merck's (MRK) new drug application for gefapixant to treat refractory chronic cough or unexplained chronic cough fails to secure approval from the FDA. Meanwhile, the drug secures approval in Japan.
WIL Research Laboratories, LLC (acquired in 2016 and renamed Charles River Laboratories Ashland, LLC) [2] was a contract research organization (CRO), privately held for 40 years, that provided product safety toxicological research, metabolism, bioanalytical, pharmacological, and formulation services to the pharmaceutical, biotechnology, chemical, agrochemical, and food products industries, as ...
This week, Freep readers weighed in on current events and ways Michigan lawmakers can enact change.
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