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Background <p>The development of a new drug is a lengthy, complex, and resource-intensive process that often spans many years. To support earlier access to therapies for serious or life-threatening conditions, the US FDA has administered several expedited development and review programs, established through legislation enacted by the U.S. Congress.</p> Objective <p>The objective of this study is to analyse how FDA expedited pathways and designation programs were utilised for new drug applications from 2020 to 2024. The focus is on identifying overall patterns and trends in the use of these regulatory mechanisms during the specified timeframe.</p> Methods <p>A descriptive analysis was conducted using publicly available FDA sources, including Drugs@FDA, Novel Drug Approvals, the Orange Book, and related review documents. Approved NDAs from 2020 to 2024 were classified by expedited approvals, therapeutic area, sponsor, and dosage form, and trends were summarised using frequency distribution.</p> Results <p>From 2020 to 2024, the USFDA granted expedited approvals to 279 NDAs, of which 37.3% carried a single designation, 28.7% held dual designations, and 34.1% incorporated multiple designations. The therapeutic landscape was led by oncology (30.5%), followed by infectious diseases (15.1%) and neurology (14.0%). A majority were Type 1 NDAs (62%) submitted under the 505(b)(1) pathway. Novartis and AstraZeneca emerged as leading sponsors, with 12 and 9 approvals, respectively. In formulation trends, oral solids, notably tablets (40.1%) and capsules (17.6%), remained dominant.</p> Conclusion <p>The USFDA’s expedited programs continue to play a crucial role in enabling timely access to groundbreaking treatments. The decline in Accelerated Approvals post-2021 aligns with the broader adoption of the Real-Time Oncology Review (RTOR) model. Together, these evolving frameworks reflect the FDA’s commitment to a more efficient, data-driven, and patient-focused regulatory system.</p>

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A Five-Year Trend Analysis of USFDA Expedited Approvals and Designations for New Drug Applications (2020–2024)

  • 期刊论文

  • 发表日期：

    2026年2月3日

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  • Kailas Vijay Gadekar,
  • Ramesh Joga,
  • Sravani Yerram,
  • Sonali Waiker,
  • Saurabh Srivastava

摘要

Background

The development of a new drug is a lengthy, complex, and resource-intensive process that often spans many years. To support earlier access to therapies for serious or life-threatening conditions, the US FDA has administered several expedited development and review programs, established through legislation enacted by the U.S. Congress.

Objective

The objective of this study is to analyse how FDA expedited pathways and designation programs were utilised for new drug applications from 2020 to 2024. The focus is on identifying overall patterns and trends in the use of these regulatory mechanisms during the specified timeframe.

Methods

A descriptive analysis was conducted using publicly available FDA sources, including Drugs@FDA, Novel Drug Approvals, the Orange Book, and related review documents. Approved NDAs from 2020 to 2024 were classified by expedited approvals, therapeutic area, sponsor, and dosage form, and trends were summarised using frequency distribution.

Results

From 2020 to 2024, the USFDA granted expedited approvals to 279 NDAs, of which 37.3% carried a single designation, 28.7% held dual designations, and 34.1% incorporated multiple designations. The therapeutic landscape was led by oncology (30.5%), followed by infectious diseases (15.1%) and neurology (14.0%). A majority were Type 1 NDAs (62%) submitted under the 505(b)(1) pathway. Novartis and AstraZeneca emerged as leading sponsors, with 12 and 9 approvals, respectively. In formulation trends, oral solids, notably tablets (40.1%) and capsules (17.6%), remained dominant.

Conclusion

The USFDA’s expedited programs continue to play a crucial role in enabling timely access to groundbreaking treatments. The decline in Accelerated Approvals post-2021 aligns with the broader adoption of the Real-Time Oncology Review (RTOR) model. Together, these evolving frameworks reflect the FDA’s commitment to a more efficient, data-driven, and patient-focused regulatory system.