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25 april 2023
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Industry bodies commented on USFDA released M11: technical specification - clinical electronic structured harmonized protocol…
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USFDA Guidance released! For Product-Specific Guidance Meetings for the ANDA applicants
20 april 2023
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Responsibilities of the marketing authorization holder concerning the qualified person responsible for pharmacovigilance (QPPV) in…
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Periodic Adverse Drug Experience Report (PADER) in a nutshell
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March 2023 Monthly Newsletter
28 march 2023
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