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All Reports and Publications

All Reports and Publications

The Food and Drug Administration’s Inspection and Recall Process Should Be Improved To Ensure the Safety of the Infant Formula Supply

Report to Congress on the Reported Impact of Discarded-Drug Refunds on Biosimilar Biological Products

The Food and Drug Administration Needs To Improve the Premarket Tobacco Application Review Process for Electronic Nicotine Delivery Systems To Protect Public Health

FDA Could Take Stronger Enforcement Action Against Tobacco Retailers With Histories of Sales to Youth and Other Violations

Supplemental Data on Tobacco Retailer Inspections

Independent Attestation Review: Food and Drug Administration Fiscal Year 2022 Detailed Accounting Submission and Budget Formulation Compliance Report for National Drug Control Activities and Accompanying Required Assertions

FDA Should Improve Its Management of Contracts for the Acquisition of Information Technology

FDA's Approach to Overseeing Online Tobacco Retailers Needs Improvement

Delays in Confirmatory Trials for Drug Applications Granted FDA's Accelerated Approval Raise Concerns

FDA's Work with the Tri-Agency Task Force for Emergency Diagnostics Helped Labs Implement COVID-19 Tests

FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing

The Food and Drug Administration's Foreign For-Cause Drug Inspection Program Can Be Improved To Protect the Nation's Drug Supply

Independent Attestation Report: Food and Drug Administration Budget Formulation Compliance Report and Detailed Accounting Submission for Fiscal Year 2021 National Drug Control Activities, and Accompanying Required Assertions

The Food and Drug Administration Needs To Improve Its Contract Closeout Processes To Identify Contracts Eligible for Closeout and Close Contracts Timely

High-expenditure Medicare drugs often qualified for Orphan Drug Act incentives designed to encourage the development of treatments for rare diseases

Risk Assessment of the Food and Drug Administration's Travel Card Program

Risk Assessment of Food and Drug Administration's Purchase Card Program

FDA's Risk Evaluation and Mitigation Strategies: Uncertain Effectiveness in Addressing the Opioid Crisis

Ownership—But Not Physical Movement—of Selected Drugs Can Be Traced Through the Supply Chain

The Food and Drug Administration Did Not Submit Clearance Documents for Any Audit Recommendations During Fiscal Years 2015 and 2016 but Has Since Made Significant Progress

All Reports and Publications

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