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TXT Drug Limited Population Pathway Guidance [2700 Words] [ Price : $8.95]
FDA publishes a guidance explaining its implementation of a 21st Century Cures provision creating a limited population pathway for new antibacterial and antifungal drugs.
08/05/2020
 
 
TXT Drug User Fee Rates for FY 2021 [85 Words] [ Price : $8.95]
Federal Register notice: FDA sets the rates for generic new animal drug user fees for fiscal year 2021.
08/04/2020
 
 
TXT Animal Drug User Fee Rates for FY 2021 [69 Words] [ Price : $8.95]
Federal Register notice: FDA announces the fee rates and payment procedures for fiscal year 2021 animal drug user fees.
08/04/2020
 
 
TXT Multiple Violations at Acrx Specialty Pharmacy [3052 Words] [ Price : $8.95]
FDA warns Acrx Specialty Pharmacy about multiple violations in its compounding of finished drugs.
08/04/2020
 
 
TXT Fishman Selling Unapproved Animal Drugs [2687 Words] [ Price : $8.95]
FDA warns Fishman Chemical that it is selling 11 unapproved new animal drugs and also continuing to market chloroquine phosphate despite receiving a Warning Letter telling it to stop.
08/04/2020
 
 
TXT MedWatch to Manufacturers Program Discontinued [2651 Words] [ Price : $8.95]
FDA drops the MedWatch to Manufacturers Program in favor of the FDA Adverse Events Reporting System public dashboard.
08/04/2020
 
 
TXT End Monopoly Control of Remdesivir: Public Citizen [2686 Words] [ Price : $8.95]
Public Citizen says Gilead’s remdesivir should be in the public domain because taxes help fund its development and the federal government co-owns some of its core patents.
08/04/2020
 
 
TXT Biotricity Gains Clearance for Bioflux Software [96 Words] [ Price : $8.95]
FDA clears a Biotricity 510(k) for its Bioflux Software II System.
08/04/2020
 
 
TXT FDA ‘Nimble’ in Pandemic Responses: Azar [2721 Words] [ Price : $8.95]
HHS secretary Alex Azar says FDA moved quickly to remove KN95 masks from Chinese manufacturers that didn’t have required independent data evaluations of their quality.
08/04/2020
 
 
TXT Comments Sought on International Controls on 11 drugs [114 Words] [ Price : $8.95]
Federal Register notice: FDA seeks comments on abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on 11 drug substances.
08/04/2020
 
 
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