Flashback Friday: FDA Approval Processes

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This week, the Food and Drug Administration (FDA) announced a new pilot program ([link removed] ) to expedite the drug review process.

For Flashback Friday, let's take a closer look at papers that have explored the topic of FDA approval processes.

First-In-Class Drugs Experienced Different Regulatory Treatment In The US And Europe ([link removed] )

Jihye Han and Aaron S. Kesselheim (March 2025)

FDA Breakthrough Therapy Designation Reduced Late-Stage Drug Development Time ([link removed] )

Kathleen L. Miller et al. (July 2024)

Characteristics Of Key Patents Covering Recent FDA-Approved Drugs ([link removed] )

Victor L. Van de Wiele et al. (August 2022)

Developing Drugs For A Developing Climate ([link removed] )

David A. Simon and I. Glenn Cohen (July 2024)

Accelerated Approval Drugs Are Not Driving Medicaid Spending ([link removed] )

Kenneth E. Thorpe and Thomas L. Johnson (June 2022)

FDA Vague Efforts to Scale Generative AI Internally By End of June ([link removed] )

Jeff Byers and Michael Gerber (May 2025)

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Nickolas Zaller et al.

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Valerie Opipari and Wesley D. Millican

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