Description
The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of complicated urinary tract infections (cUTIs).2 Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the overall development program and clinical trial designs for drugs to support an indication for the treatment of cUTIs.
Scope & Applicability
Product Classes
3Licensed under section 351 of the Public Health Service Act.
Drugs used to treat B. burgdorferi or B. mayonii infections
Drugs used for the treatment of cUTI
Stakeholders
4Entity responsible for submitting applications under section 524B
Specific patient population identified by baseline culture
All patients who were randomized in the clinical trial.
The primary analysis population consisting of randomized patients with a baseline pathogen.
Regulatory Context
Attributes
6Statistical considerations for cUTI trials
The noninferiority margin, recommended at 10 percent
treatment effect of the active-comparator drug that can be reliably distinguished from placebo
Justification essential for trials using a noninferiority design
Condition that can influence drug concentrations in serum and urine.
The supported margin for cUTI trials based on historical evidence.
Related CFR Sections (1)
- 21CFR314.600§ 314.600 Scope.
This subpart applies to certain new drug products that have been studied for their safety and efficacy in ameliorating or preventing serious or life-threatening conditions caused by exposure to lethal or permanently disabling toxic biological, chemical, radiological, or nuclear substances. This subpRead full regulation →
See Also (8)
- Guidance for Industry: Acute Bacterial Otitis Media: Developing Drugs for Treatment (Status: Final)
- Acute Bacterial Sinusitis — Developing Antimicrobial Drugs for Treatment (Status: Final)
- Neglected Tropical Diseases of the Developing World: Developing Drugs for Treatment or Prevention (Status: Final)
- Product Development Under the Animal Rule (Status: Final)
- Emergency Use Authorization of Medical Products and Related Authorities: Guidance for Industry and Other Stakeholders (Status: Final)
- Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases (Status: Final)
- Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products: Draft Guidance for Industry (Status: Draft)
- Mpox: Development of Drugs and Biological Products; Guidance for Industry (Status: Draft)