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FDA Updates Woodside Acquisitions’ Covid Tests Recall
[95 Words]
[ Price : $8.95]
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| FDA updates a Class 1 recall notice involving Woodside Acquisitions’ Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit and the Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold). |
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06/10/2022
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Info Collection on Dietary Supplement Notifications
[71 Words]
[ Price : $8.95]
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| Federal Register notice: FDA sends to OMB an information collection extension entitled “Food Labeling: Notification Procedures for Statements on Dietary Supplements — 21 CFR 101.93.” |
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06/10/2022
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GSK Positive Data from Respiratory Virus Vaccine Trial
[241 Words]
[ Price : $8.95]
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| GSK announces positive data from a pre-specified efficacy interim analysis of its AReSVi 006 Phase 3 trial evaluating the company’s respiratory syncytial virus vaccine candidate. |
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06/10/2022
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FDA Inspection at Bioberica Nets 5-item 483
[188 Words]
[ Price : $8.95]
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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 at the drug substance manufacturing facility. |
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06/10/2022
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CBER Plans to Normalize Operations in 2023
[231 Words]
[ Price : $8.95]
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| CBER updates its prioritization schedule for the remainder of 2022 to account for Covid-19-related work, while it plans to return to normal operating procedures in 2023. |
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06/10/2022
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LabCorp Gains EUA for Covid Lineage Test
[126 Words]
[ Price : $8.95]
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| FDA grants an emergency use authorization for Laboratory Corp. of America’s VirSeq SARS-CoV-2 NGS Test on the PacBio Sequel II sequencing system to aid in identifying Covid-19 lineages. |
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06/10/2022
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Green Pharma Recalls SnoreStop Lot
[107 Words]
[ Price : $8.95]
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| Green Pharmaceuticals recalls one lot of its SnoreStop NasoSpray after FDA testing found the product contained a microbial contamination identified as Providencia rettgeri. |
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06/10/2022
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FDA Clears 2 Thermo Scientific Tests
[161 Words]
[ Price : $8.95]
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| 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 sclerosis and systemic lupus erythematosus. |
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06/09/2022
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DoJ Defends 'Fraud-on-FDA' in 1 Specific Case
[324 Words]
[ Price : $8.95]
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| Sidley attorneys say the Justice Department voiced strong support for a fraud-on-FDA theory of liability in a case involving blood glucose meters. |
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06/09/2022
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