US FDA under scrutiny: the latest reports on PMTA progress

On 15th April 2022, the US District Court for the District of Maryland ordered the Food and Drug Administration (FDA) to submit regular reports on the premarket tobacco product application (PMTA)’s review progress to the court. These updates only cover a certain number of applications, and do not cover all of the current PMTAs under review.

This report discusses the background to this decision, examines the timeline of these updates and provides analysis of the FDA’s progress.

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Table of contents

  1. Executive summary
  2. Background
  3. Timeline
  4. Analysis
  5. Forecasts and actual progress compared
  6. Can the FDA achieve its 100% forecast by the end of 2023?

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