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Hello,  thank you so much for taking the time to answer, I highly appreciate it! I have now asked twice for them to clarify what language triggers the need for an IND and they have not answered. They insist on "a letter from the FDA that an IND is not necessary". They said that they discussed extensively but won't share the content of the discussion ...

Hello RAC Community, I am trying to develop a list of regulations both (US and EU) that govern Pharmaceuticals, Clinical and Laboratory.  Any help or website recommendations that ware easy to navigate is appreciated.  Thank you, L.C. Hemphill ------------------------------ Latricia Hemphill Quality Engineer Farmington Hills MI United States -- ...

I once worked on class II Medical film printer that printed 48" long films. Surgeons would take an X-Ray of the patient's leg(s) and then print out the film and lay the film (or paper print) next to the patient on the surgery table. They could then anatomically compare the patient's leg and the printout to guide their surgery.  Our intended use was ...

Two years after Japan began employing a cost-effectiveness evaluation system to determine the efficiency and allocation of health resources, it is preparing for the first time to adjust prices of pharmaceuticals and medical devices based on such assessments. Japan's Central Social Insurance Medical Council (Chuikyo) is expected to discuss the potential ...

Dear drugs CMC folks, I think it's very challenging to plan and implement CMC post-approval changes in multiple regions . What is your advice to set an efficient strategy for the change roll-out? Also, How to handle the discrepancies that may rise in the different authorities inquires? For example, one authority may insist on making a change in ...