Regulatory expectations and requirements continue to evolve to ensure the quality and safety of drug products. Over the last five years, we have seen increased focus during regulatory inspections ...
MINNEAPOLIS, June 10, 2021 (GLOBE NEWSWIRE) -- CVRx®, developer of the world’s first FDA-approved neuromodulation device to treat the symptoms of heart failure (HF), announced the completion of the ...
Are you ready for ICH Q14: Analytical Procedure Development and the revision of ICHQ2(R1) Analytical Validation? These guidance’s, intended to be published by 2021, complement Q8 to Q12 and aim to ...
Scott Zellner: This method formalizes a prescribed surgical technique which uses tools like the Hana Table and intra-operative imaging that enhances the surgeon’s ability to perform the procedure and ...
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