Tag Archive: enforcement discretion

Oct 10 2012

Clinical Trial Reporting

On 26 September 2012, a notice was published in the Federal Register that the Department of Health and Human Services was transferring responsibility to the FDA for ensuring that clinical trial data is appropriately submitted to Clinical Trial Registry and Results Data Bank (which is also known as ClinicalTrials.gov) and that the data is complete …

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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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