Current FDA Regulatory Strategies for Accelerated Development and Approval of New Antibiotics: a Review and Practical Considerations for Developers

Background. The global antimicrobial resistance (AMR) crisis, exacerbated by the shortage of new antibiotics due to economic and regulatory barriers, poses a particular threat to the Russian Federation. The US Food and Drug Administration (FDA) has developed a number of adaptive regulatory approaches to address the AMR crisis. This experience can be used as a basis for addressing this problem in Russia. The aim of this review is to analyze the evolution, criteria, and practical effectiveness of key FDA programs for accelerated approval of new antibacterial drugs: Fast Track (FT), Breakthrough Therapy (BT), Qualified Infectious Disease Product (QIDP) designation, and Limited Population Pathway for Antibacterial Drugs (LPAD), as well as to assess the potential for applying this experience to improve regulatory practices in the Russian Federation.

Material and Methods. A review of US legislation, FDA regulatory guidance, scientific publications, and public reports on approved drugs (2010–2025) was conducted. The criteria, benefits, and practical aspects of each program were organized systematically.

Results. The characteristics and advantages of each program are organized systematically. It is shown that QIDP status, which provides automatic FT assignment, priority review, and 5 years of additional market exclusivity, has become a key factor in the approval of most new antibiotics. The essence of the LPAD pathway is a fundamentally new approach: drug approval for a limited patient population is possible based on a reduced amount of clinical information. Examples of successful implementation of these programs (ceftolozane/tazobactam, ceftazidime/avibactam) are provided.

Conclusion. The FDA's experience demonstrates that specialized regulatory measures can accelerate the development of new antibiotics. For the Russian Federation, integrating adapted QIDP and LPAD principles into the national regulatory system appears to be a promising approach to overcoming the AMR crisis.

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