clinical trial exemption


Also found in: Acronyms.

clinical trial exemption (CTX)

authorization to administer an investigational agent to patients or volunteer subjects under specified conditions of a particular research study in a clinical setting.

clinical trial exemption

A UK scheme that allows drug sponsors to apply for approval for each clinical study in turn, submitting supporting data to the Medicines Control Agency (MCA), which approves or rejects the application; approval circumvents the need to hold a clinical trial certificate (CTC).
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References in periodicals archive ?
Judge McKelvie's ruling recognizes the limits of the clinical trial exemption allowed under the statute and helps ensure that the activities of a competitor are exposed to appropriate regulatory scrutiny," said William A.
District Court of Massachusetts in Boston granted their motion for summary judgment of non-infringement on the grounds that the activities of TKT and HMR to date were protected by the clinical trial exemption.
The Company's latest European regulatory filing was daptomycin's Clinical Trial Exemption (CTX) for clinical evaluation in the United Kingdom.
The UK Medicines Control Agency (MCA) granted a Clinical Trial Exemption (CTX) and the French Medicines Agency granted approval to proceed.
Viragen recently filed its application for Clinical Trial Exemption (CTX) in the United Kingdom with the Medicines Control Agency.
Viragen recently filed a Clinical Trial Exemption (CTX) Application with the regulatory authorities in the United Kingdom in association with the Scottish National Blood Transfusion Service to commence hepatitis C Clinical trials.
Viragen recently filed a Clinical Trial Exemption (CTX) Application with the Medicines Control Agency (MCA), the governing body that regulates therapeutic drugs in the United Kingdom.
The study was undertaken in 50 patients with dermal ulcers, mainly heels and sacral area, under a new drug clinical trial exemption from the British government.
Department of Health has cleared the company's Clinical Trial Exemption (CTX) application to allow Telor to begin Phase III trials for XARANO(TM) in the United Kingdom.
NASDAQ: BSTC) announced today that its collagenase-based ointment has received Clinical Trial Exemption (CTX) in England.

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