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TXT American Medical Aesthetics’ Stem Cell Products [2723 Words] [ Price : $8.95]
CBER says American Medical Aesthetics and Regenerative Medicine is marketing stem cell products without a valid BLA in place.
07/28/2020
 
 
TXT FDA Posts Animal Drug Application Actions [81 Words] [ Price : $8.95]
Federal Register notice: FDA amends the animal drug regulations to reflect application-related actions made during January, February, and March.
07/28/2020
 
 
TXT Latest FDA Warning Letters [249 Words] [ Price : $8.95]
FDA releases its latest batch of Warning Letters that includes Eosera and Tender Corp.
07/28/2020
 
 
TXT House Passes FDA Spending Bill with $41 Million Boost [571 Words] [ Price : $8.95]
The U.S. House of Representatives passes an FDA spending bill that sets the agency’s 2021 discretionary funding at $3.212 billion, an increase of $40.8 million above the 2020 enacted level.
07/28/2020
 
 
TXT Guided Therapeutics Study Protocol for Cervical Scan [287 Words] [ Price : $8.95]
Guided Therapeutics says it has submitted a clinical study protocol to FDA to support marketing of its LuViva Advanced Cervical Scan.
07/28/2020
 
 
TXT Vaccines ‘Remarkably Safe’ Over Last 20 Years [2682 Words] [ Price : $8.95]
Israeli researchers say FDA has a robust vaccine approval and postmarketing surveillance system that worked well over the 20 years they studied.
07/28/2020
 
 
TXT Woodcock and Colleagues Defend ‘Integrated Reviews’ [2742 Words] [ Price : $8.95]
CDER director Janet Woodcock defends the Center’s use of integrated reviews from criticisms that they won’t meet agency goals and may introduce new problems.
07/28/2020
 
 
TXT Moderna Begins Dosing in Phase 3 Covid Vaccine Trial [313 Words] [ Price : $8.95]
Moderna says it has begun dosing participants in its Phase 3 study of its mRNA vaccine candidate for Covid-19.
07/27/2020
 
 
TXT Indivior Pays $600 Million in Opioid Marketing Case [402 Words] [ Price : $8.95]
Indivior Solutions pleads guilty to one felony count and agrees to pay a total of $600 million to resolve criminal and civil liability associated with the marketing of the opioid-addiction-treatment Suboxone (buprenorphine).
07/27/2020
 
 
TXT More Data Requested to Lift Hold on Solid Duchenne Drug [325 Words] [ Price : $8.95]
FDA requests additional data and manufacturing information from Solid Biosciences to potentially lift a clinical hold on the company’s Phase 1-2 IGNITE DMD clinical trial that is evaluating SGT-001 in Duchenne muscular dystrophy.
07/27/2020
 
 
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