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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Results may differ materially depending on the progress of BioMarin's product programs, the results of current and proposed clinical trials, actions of regulatory authorities, including the Medicines Control Agency's actions on the Clinical Trial Exemption application, availability of capital, future actions in the pharmaceutical market and developments by competitors, and those factors detailed in BioMarin's filings with the Securities and Exchange Commission such as 10Q, 10K and 8K reports.
District Court in Delaware has issued a ruling in Nexell's suit against Miltenyi Biotec/AmCell Corporation that clarifies the scope of the clinical trial exemption provided under section 271(e)(1) of the patent statute.
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.
In the United Kingdom, Clinical Trial Exemption certificate (CTX) applications have been submitted for studies to begin in ovarian and colorectal cancer patients.

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