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CLIA and FDA:  Where are we going?  August 2019 Glen Paul Freiberg, RAC   After more than 30 years, I remain upset about the creation and evolution of CLIA 88, the Clinical Laboratory Improvement Amendments of 1988, and commensurate regulations, which revised and expanded the original ...

I'd like to add a bit more detail to the listing below: The software used to generate the information below should allow for sorting by date, lot/serial number and, most important, print out each recipient's name/address/contact just once. Sometimes this last item is more difficult because the "contact ...

Another aspect of this guidance is FDA slipping in the photography justification. Refusal for photography is not an inspection refusal. While FDA gives limited examples of why photos would be helpful, the argument about allowing companies to exclude photography as part of company policy - as far as I ...

On June 13, 2013, the FDA's Microbiology Advisory panel will discuss and make recommendations regarding the possible reclassification of influenza detection devices, currently regulated as class I. The committee's specific discussion will involve making recommendations regarding regulatory classification ...