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03 APR 2024 | BY RYAN CONNORS
INTRODUCING THE RAPS BELGIUM LOCAL NETWORKING GROUP
02 APR 2024 | BY JOANNE S. EGLOVITCH
FDA TURNS ATTENTION TO DATA INTEGRITY LAPSES AT TESTING SITES IN NEW GUIDANCE
The US Food and Drug Administration (FDA) has issued a draft guidance outlining
how manufacturers can ensure the data integrity of bioavailability (BA) and
bioequivalence (BE) studies to suppo...
02 APR 2024 | BY JENNIE SMITH
LATIN AMERICA ROUNDUP: MEXICO, EL SALVADOR JOIN IMDRF AS AFFILIATES
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Forum (IMDRF) accepted submissions from Mexico and El Salvador’s national
regulatory authorities to join the foru...
02 APR 2024 | BY JASON SCOTT
RECON: FDA APPROVES ABBOTT’S TRICLIP HEART VALVE REPAIR DEVICE; TEVA, VIATRIS
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RE: infusion pump per CFR 880.5725
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Dear Richard and Ryan Yes, I will certainly come by and say hello. I hope that
we will be hearing how the planning of the revision of the MDR is...
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