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TXT FDA Wants Doctors to Discuss Naloxone with Patients [2688 Words] [ Price : $8.95]
FDA says healthcare professionals should discuss naloxone with patients taking opioid pain medicines or drugs for opioid use disorder and consider prescribing naloxone for those patients.
07/23/2020
 
 
TXT Fresenius Recalls 2 Lots Dexmedetomidine [109 Words] [ Price : $8.95]
Fresenius Kabi recalls two lots of dexmedetomidine HCl in 0.9% sodium chloride injection due to the possibility of a trace amount of lidocaine present in the two lots.
07/23/2020
 
 
TXT FDA Warns Clinics on Unapproved Covid ‘Cures’ [2763 Words] [ Price : $8.95]
FDA and the Federal Trade Commission says Create Wellness Clinics is marketing several types of unapproved products intended to treat Covid-19.
07/23/2020
 
 
TXT Many Recalls in Healthcare Deployment of Devices: Report [2669 Words] [ Price : $8.95]
Internet of Things (IoT) security firm Ordr says many IoT medical devices have been subject to FDA recall as defective or risky.
07/23/2020
 
 
TXT Senate Bill on FDA Seizing/Detroying Counterfeit Devices [129 Words] [ Price : $8.95]
U.S. senators Mike Enzi (R-WY) and Maggie Hassan (D-NH) introduce legislation that would help protect patients from counterfeit medical products that could cause serious harm.
07/23/2020
 
 
TXT Guide on Human Cell Tissue Products [115 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled “Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P): Minimal Manipulation and Homologous Use.”
07/22/2020
 
 
TXT Don’t License Mesoblast’s Ryoncil: Petition [2789 Words] [ Price : $8.95]
A Lassman Law & Policy petition asks FDA to require substantial evidence of effectiveness before approving a BLA for Mesoblast’s Ryoncil.
07/22/2020
 
 
TXT Positive CDER Response to Liver Safety Biomarker [2640 Words] [ Price : $8.95]
CDER accepts a C-Path qualification plan for glutamate dehydrogenase as a safety biomarker for drug-induced liver injury.
07/22/2020
 
 
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Federal Register notice: FDA makes available a draft guidance on quality considerations for cannabis and cannabis-derived compounds.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
 
 
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