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TXT FDA Updates Woodside Acquisitions’ Covid Tests Recall [95 Words] [ Price : $8.95]
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).
06/10/2022
 
 
TXT Info Collection on Dietary Supplement Notifications [71 Words] [ Price : $8.95]
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.”
06/10/2022
 
 
TXT Info Collection on Tropical Disease Vouchers [97 Words] [ Price : $8.95]
Federal Register notice: FDA submits to OMB an information collection extension entitled “Tropical Disease Priority Review Vouchers.”
06/10/2022
 
 
TXT GSK Positive Data from Respiratory Virus Vaccine Trial [241 Words] [ Price : $8.95]
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.
06/10/2022
 
 
TXT FDA Inspection at Bioberica Nets 5-item 483 [188 Words] [ Price : $8.95]
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.
06/10/2022
 
 
TXT CBER Plans to Normalize Operations in 2023 [231 Words] [ 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 to normal operating procedures in 2023.
06/10/2022
 
 
TXT LabCorp Gains EUA for Covid Lineage Test [126 Words] [ Price : $8.95]
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.
06/10/2022
 
 
TXT Green Pharma Recalls SnoreStop Lot [107 Words] [ Price : $8.95]
Green Pharmaceuticals recalls one lot of its SnoreStop NasoSpray after FDA testing found the product contained a microbial contamination identified as Providencia rettgeri.
06/10/2022
 
 
TXT FDA Clears 2 Thermo Scientific Tests [161 Words] [ 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 sclerosis and systemic lupus erythematosus.
06/09/2022
 
 
TXT DoJ Defends 'Fraud-on-FDA' in 1 Specific Case [324 Words] [ 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 glucose meters.
06/09/2022
 
 
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