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TXT FDA Clears Dental Caries AI Detector [98 Words] [ Price : $8.95]
FDA clears a VideaHealth 510(k) for its Videa Caries Assist, an artificial intelligence-powered dental caries (cavity) detection algorithm.
05/05/2022
 
 
TXT FDA Limits Use of Janssen Vaccine Due to Clot Risk [385 Words] [ Price : $8.95]
FDA limits the emergency use authorization of Janssen’s Covid-19 vaccine to certain individuals 18 years of age and older due to the risk of thrombosis with thrombocytopenia syndrome.
05/05/2022
 
 
TXT CDER Study Verifies Continuous Manufacturing Benefits [2754 Words] [ Price : $8.95]
Eleven CDER staffers say a Center self-audit of continuous manufacturing regulatory submissions verifies the benefits the agency has seen in such technologies.
05/05/2022
 
 
TXT FDA Approves Enhertu for Some Additional Breast Cancers [2777 Words] [ Price : $8.95]
FDA approves a new indication for Daiichi Sankyo’s Enhertu for some breast cancer patients.
05/05/2022
 
 
TXT Switching Generic Levothyroxine Maintains Thyroid Function: Study [2719 Words] [ Price : $8.95]
FDA-sponsored research demonstrates that patients who switch between generic levothyroxine products maintain the same level of thyroid function as patients who use a single product.
05/05/2022
 
 
TXT 15 Observations in Qualgen FDA-483 [2982 Words] [ Price : $8.95]
FDA releases the FDA-483 with 15 observations issued following an inspection at the Edmond, OK-based Qualgen outsourcing facility.
05/05/2022
 
 
TXT Correlating Device Inspections with Warning Letters [2761 Words] [ Price : $8.95]
Attorney Bradley Thompson uses data analysis to determine medical device inspection observations that more frequently are associated with Warning Letters.
05/04/2022
 
 
TXT Anesthetic/Analgesic Drugs Panel Renewal [62 Words] [ Price : $8.95]
Federal Register notice: FDA announces its renewal of the Anesthetic and Analgesic Drug Products Advisory Committee for an additional two years beyond the charter expiration date.
05/04/2022
 
 
TXT Guide on Circulating Tumor DNA Drug Development [95 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled “Use of Circulating Tumor DNA for Early-Stage Solid Tumor Drug Development.”
05/04/2022
 
 
TXT More Transparency in Advisory Committee Use Needed: Researchers [2801 Words] [ Price : $8.95]
Harvard University researchers who looked at FDA’s use of advisory committees for new drugs say reforms in the process would improve transparency and accountability.
05/04/2022
 
 
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