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  • Hi Anon, In the Pharma sector, QA and RA are usually separate entities. QA deals with the GMP. In some others QA also deals with health & safety or even HR. In small companies you can see only one department (QA/RA). It really depends on the people. If they are interested and they are versatile, you can combine them all to one. The problem is the ...

  • Hi Anon, I do not think it is expected a side to side comparison of the IFU, as long as the intended purpose is the same. Is it so difficult to have access to the IFU? You should consider demonstrating the equivalence through material and chemical characterization. You will retrieve valuable information in order to demonstrate that your device is ...

  • Dear Ames, thank you for this info. Will this only be true for pharmaceuticals, or also for medical devices? All the Best ------------------------------ Markus Lantermann Mannheim Germany ------------------------------

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    RE: Submission Date in FDA Forms and Cover Letter

    This message was posted by a user wishing to remain anonymous I think it is better to have it as the day of submission so if you are every looking back at the submission, you know for sure when it was submitted. I usually look at the cover letter. I will say that I have at times signed the 1571 electronically 1 business day (so Friday before a Monday ...

  • Dear Pharmacovigilance and Regulatory colleagues ,   I was hoping that you might be able to provide some advice on unblinding of SUSARs to health authorities when the event is thought related to the comparator product (ie APPROVED PRODUCT A).  We have an ongoing study of APPROVED PRODUCT A with placebo (SOC) vs. APPROVED PRODUCT A + our investigational ...

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