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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 was founded in 1947 by Henry Foster, a young veterinarian who purchased one thousand rat cages from a Virginia farm and set up a one-person laboratory in Boston overlooking the Charles River. To fulfill the regional need for laboratory animal models, he bred, fed, and cared for the animals and personally delivered them to local ...
Chemistry Research Laboratory, University of Oxford, the main chemistry building at Oxford University Complete Response Letter , the official FDA response to a New Drug Application Crown-rump length , the ultrasound measurement of a foetus
AOL
Code words – a single classified word (e.g. BYEMAN) which identifies a specific special access program or portion. A list of several such code words can be seen at Byeman Control System. Exercise terms – a combination of two words, normally unclassified, used exclusively to designate an exercise or test [1]
A test panel is a predetermined group of medical tests used in the diagnosis and treatment of disease.. Test panels (sometimes called profiles) are typically composed of individual laboratory tests which are related in some way: by the medical condition they are intended to help diagnose (cardiac risk panel), by the specimen type (complete blood count, CBC), by the tests most frequently ...
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.
Administrative Controlled Substances Code Number (ACSCN) is a number assigned to drugs listed on the schedules created by the US Controlled Substances Act (CSA). The ACSCN is defined in 21 CFR § 1308.03(a). Each chemical/drug on one of the schedules is assigned an ACSCN (for example, heroin is assigned 9200). The code number is used on various ...