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Human Drugs

Drug Limited Population Pathway Guidance

FDA publishes a guidance explaining its implementation of a 21st Century Cures provision creating a limited population pathway for new antibacterial a...

Federal Register

Drug User Fee Rates for FY 2021

Federal Register notice: FDA sets the rates for generic new animal drug user fees for fiscal year 2021.

Federal Register

Animal Drug User Fee Rates for FY 2021

Federal Register notice: FDA announces the fee rates and payment procedures for fiscal year 2021 animal drug user fees.

Human Drugs

Multiple Violations at Acrx Specialty Pharmacy

FDA warns Acrx Specialty Pharmacy about multiple violations in its compounding of finished drugs.

Animal Drugs

Fishman Selling Unapproved Animal Drugs

FDA warns Fishman Chemical that it is selling 11 unapproved new animal drugs and also continuing to market chloroquine phosphate despite receiving a W...

Human Drugs

MedWatch to Manufacturers Program Discontinued

FDA drops the MedWatch to Manufacturers Program in favor of the FDA Adverse Events Reporting System public dashboard.

Human Drugs

End Monopoly Control of Remdesivir: Public Citizen

Public Citizen says Gileads remdesivir should be in the public domain because taxes help fund its development and the federal government co-owns some ...

Medical Devices

Biotricity Gains Clearance for Bioflux Software

FDA clears a Biotricity 510(k) for its Bioflux Software II System.

Medical Devices

FDA Nimble in Pandemic Responses: Azar

HHS secretary Alex Azar says FDA moved quickly to remove KN95 masks from Chinese manufacturers that didnt have required independent data evaluations o...

Federal Register

Comments Sought on International Controls on 11 drugs

Federal Register notice: FDA seeks comments on abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on 11 ...