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TXT AI Has Usefulness for Pharmacovigilance: Report [2796 Words] [ Price : $8.95]
CDER Office of Surveillance and Epidemiology executives discuss the potential use of artificial intelligence in pharmacovigilance activities.
05/18/2022
 
 
TXT Oryx Dental Imaging Integrator Cleared [128 Words] [ Price : $8.95]
FDA clears an Oryx Dental 510(k) for its imaging product, Oryx Imaging that allows health professionals to acquire, view, annotate, and organize dental radiographs and color images.
05/18/2022
 
 
TXT FDA Clears CTL Amedica Pedicle Screw Navigator [92 Words] [ Price : $8.95]
FDA clears a CTL Amedica 510(k) to market the CTL Amedica Navigation Instrument System for use in pedicle screw preparation and placement.
05/18/2022
 
 
TXT Label Safety Considerations Guidance [2692 Words] [ Price : $8.95]
FDA publishes a guidance with principles and recommendations to ensure that critical elements of a product’s container label and carton labeling are designed to promote safe dispensing, administration, and use of the product.
05/18/2022
 
 
TXT House Commerce Committee Moves User Fee Bill to Floor Vote [463 Words] [ Price : $8.95]
The House Energy and Commerce Committee unanimously votes (55 to 0) to advance the Food and Drug Amendments of 2022, bipartisan legislation that would reauthorize the agency’s user fee programs and modernize certain programs, such as accelerated approval for drugs, boosting FDA’s inspection authorities, and improving patient diversity in clinical studies.
05/18/2022
 
 
TXT Multiple CGMP Violations at Colorful Products [2859 Words] [ Price : $8.95]
FDA warns Newbury Park, CA-based Colorful Products about CGMP violations in its manufacturing of over-the-counter topical drug products and hand sanitizers.
05/17/2022
 
 
TXT API Deviations at Specialty Process Labs [2871 Words] [ Price : $8.95]
FDA warns Phoenix, AZ-based Specialty Process Labs about deviations from CGMP requirements for active pharmaceutical ingredients.
05/17/2022
 
 
TXT FDA Authorizes Kids’ Pfizer Covid Vaccine Booster [2646 Words] [ Price : $8.95]
FDA authorizes a single booster shot of the Pfizer/BioNTech Covid-19 vaccine in children aged 5-11.
05/17/2022
 
 
TXT FDA Accepts scPharmaceuticals NDA for Furoscix [127 Words] [ Price : $8.95]
FDA accepts for review an scPharmaceuticals NDA for Furoscix (furosemide) delivered through an on-body infusor for treating congestion in patients with worsening heart failure.
05/17/2022
 
 
TXT Guide on Container Labeling Safety Considerations [122 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors.”
05/17/2022
 
 
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