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TXT Questions on FDA Response to Antibody Scams [2770 Words] [ Price : $8.95]
Four House Energy and Commerce Committee Democrats ask FDA for information on its response to fraudulent Covid-19 antibody test scams.
07/22/2020
 
 
TXT Draft Guide on Cannabis and Cannabis-Derived Compounds [90 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance on quality considerations for cannabis and cannabis-derived compounds.
07/22/2020
 
 
TXT FDA Backs Bioinformatics Computations/Analyses Standard [85 Words] [ Price : $8.95]
Federal Register notice: FDA announces its support for use in regulatory submissions of the current version of an international standard for bioinformatics computations and analyses.
07/22/2020
 
 
TXT Congresspeople Question Drug Dog Tests [2863 Words] [ Price : $8.95]
Some 18 members of Congress ask FDA to report on its regulatory requirements and recommendations for testing drugs on dogs.
07/22/2020
 
 
TXT Cancer Patients Have Greater Covid Risk: OCE Analysis [2676 Words] [ Price : $8.95]
The FDA Oncology Center of Excellence says its analysis of real-world data shows that cancer patients with Covid-19 are at greater risk of hospitalization and death.
07/22/2020
 
 
TXT Integra LifeSciences Ultrasonic Surgical Device Cleared [103 Words] [ Price : $8.95]
FDA clears an Integra LifeSciences 510(k) for its Cusa Clarity Ultrasonic Surgical Aspirator System for use in neurosurgery for resection of tumors.
07/22/2020
 
 
TXT BD Expanded HPV Assay Approved [179 Words] [ Price : $8.95]
FDA approves a Becton, Dickinson PMA supplement for an expanded version of its BD Onclarity Human Papillomavirus (HPV) Assay.
07/22/2020
 
 
TXT FDA Preparing for Combined Flu/Covid-19 Tests This Fall [434 Words] [ Price : $8.95]
FDA commissioner Stephen Hahn says the agency is evaluating several different tests that can simultaneously test for both the flu and Covid-19 as part of its preparation for fall and winter.
07/22/2020
 
 
TXT CGMP Deviations at Mexican Signa Facility [2711 Words] [ Price : $8.95]
FDA warns Canada’s Signa SA de CV about CGMP violations at its Toluca, Mexico, API manufacturing facility.
07/21/2020
 
 
TXT Centurion Medical Products Kit Issues [2757 Words] [ Price : $8.95]
FDA warns Centurion Medical Products about manufacturing and distributing unapproved medical device/drug combination sterile convenience kits.
07/21/2020
 
 
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