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An FDA January inspection at Bioiberica (Barcelona, Spain) leads to a five-item Form FDA-483 that cited significant GMP violations...[ Price : $8.95]
CBER updates its prioritization schedule for the remainder of 2022 to account for Covid-19-related work, while it plans to return ...[ Price : $8.95]
FDA grants an emergency use authorization for Laboratory Corp. of Americas VirSeq SARS-CoV-2 NGS Test on the PacBio Sequel II sequ...[ Price : $8.95]
Green Pharmaceuticals recalls one lot of its SnoreStop NasoSpray after FDA testing found the product contained a microbial contami...[ Price : $8.95]
FDA clears Thermo Scientific 510(k)s for its EliA RNA Pol III and EliA Rib-P tests for aiding in the diagnosis of systemic scleros...[ Price : $8.95]
Sidley attorneys say the Justice Department voiced strong support for a fraud-on-FDA theory of liability in a case involving blood...[ Price : $8.95]
FDA cautions consumers not to use products marketed as mole or skin tag removers.[ Price : $8.95]
FDA approves a Foundation Medicine PMA for its FoundationOne CDx to be used as a companion diagnostic for the two approved indicat...