Flashback Friday: FDA Approval Processes
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Dear John,

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This week, the Food and Drug Administration (FDA) announced a new pilot program 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.

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First-In-Class Drugs Experienced Different Regulatory Treatment In The US And Europe

Jihye Han and Aaron S. Kesselheim (March 2025)

 

FDA Breakthrough Therapy Designation Reduced Late-Stage Drug Development Time

Kathleen L. Miller et al. (July 2024)

 

Characteristics Of Key Patents Covering Recent FDA-Approved Drugs

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

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Developing Drugs For A Developing Climate

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

 

Accelerated Approval Drugs Are Not Driving Medicaid Spending

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

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FDA Vague Efforts to Scale Generative AI Internally By End of June

Jeff Byers and Michael Gerber (May 2025)

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Supplemental Benefits in Medicare Advantage: Understanding the Challenges, Improving Effectiveness

Join Health Affairs for a free virtual event featuring insights from a year-long special series, Supplemental Benefits In Medicare Advantage.

 

On July 8, Health Affairs’ Kathleen Haddad will moderate a discussion with a panel of experts on how well MA supplemental benefits fill the health care and non-medical health related needs of MA enrollees.

 

Speakers include:

  • Narda Ipackhi, The SCAN Foundation
  • Eric Roberts, University of Pennsylvania
  • Claire Cruse, ATI Advisory
  • Chris Esguerra, Health Plan of San Mateo
  • Andy Friedell, Helper Bees

This event is open for all to attend.

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Published Today

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President Trump’s Executive Order And The Wrongful Suspension Of Pediatric Gender Care

Craig Konnoth

 

The Critical Role Of Federal Funding In Combating Firearm Violence

Nickolas Zaller et al.

 

We Must Act Now to Address The Pediatric Specialty Care Crisis

Valerie Opipari and Wesley D. Millican

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