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
- Executive summary
- Forecasts and actual progress compared
- Can the FDA achieve its 100% forecast by the end of 2023?
Our research is completely independent and original. It is conducted by ECigIntelligence’s multilingual legal analysis team, all specialists in this sector, and goes through a rigorous review and editing process before publication. Research draws on multiple sources, including: online and offline resources and data, specialist legal software, our own extensive databases and report archives, interviews with key stakeholders and government officials, and collaboration with local legal firms and on-the-ground professionals in the jurisdictions covered.