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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]
This response may be a decision to approve the application or a Complete Response Letter (CRL). The PDUFA date may be extended by the Food and Drug Administration in certain circumstances. [6] These include circumstances such as a 'major amendment', e.g. where data submitted to a final study report is updated or data inadvertently omitted is ...
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 ...
A case report form (or CRF) is a paper or electronic questionnaire specifically used in clinical trial research. [1] The case report form is the tool used by the sponsor of the clinical trial to collect data from each participating patient.
The CTD is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries.
Logical Observation Identifiers Names and Codes (LOINC) is a database and universal standard for identifying medical laboratory observations. First developed in 1994, it was created and is maintained by the Regenstrief Institute , a US nonprofit medical research organization.
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