Tag Archive: clinical supplies

Jun 12 2012

PET Drugs – Time to file that NDA, ANDA or IND

No more Nice Guy.  FDA is stopping Enforcement Discretion for facilities producing positron emission tomography (PET) drugs for clinical use effective Tuesday, 12 June 2012. The long and tortured history of PET Drug products regulation began in 1997, when Congress passed the Food and Drug Administration Modernization Act (FDAMA).  One of the sections in this …

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Aug 06 2010

Medical Imaging in Clinical Trials

Image via Wikipedia The evolution of medical imaging has greatly improved the rate and accuracy of diagnosis of disease in patients, this in turn has led to more timely treatment, and ultimately better prognosis for patients.  Imaging during clinical trials is critical in the staging of disease for subjects at enrolment, following the progress of …

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Jun 23 2010

Adaptive Designs and Clinical Supplies

In a recent post, John Johnson discussed the FDA’s draft guidance on Adaptive Design Clinical Trials for Drugs and Biologics, particularly in the context of planning and designing a clinical trial.  My perspective concerns challenges related to clinical supplies (CS) presented by adaptive trial designs. FDA defines an adaptive design clinical study as “a study …

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