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FT 2021 User Fee Rates for Outsourcing Facilities

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Federal Register notice: FDA announces fiscal year 2021 user fee rates for the establishment and re-inspection fees for entities t...

Comments on FDA Data Strategy Modernization

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Four stakeholders comment on early FDA plans to modernize its data strategy.

MasterPharm FDA-483 Released

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FDA releases an FDA-483 with seven observations from its inspection at MasterPharm, a producer of sterile and non-sterile drug pro...

Drug Limited Population Pathway Guidance

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

Drug User Fee Rates for FY 2021

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

Animal Drug User Fee Rates for FY 2021

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

Multiple Violations at Acrx Specialty Pharmacy

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

Fishman Selling Unapproved Animal Drugs

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

MedWatch to Manufacturers Program Discontinued

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

End Monopoly Control of Remdesivir: Public Citizen

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Public Citizen says Gileads remdesivir should be in the public domain because taxes help fund its development and the federal gove...