Description
The purpose of this guidance is to assist sponsors in clinical drug development for the treatment of adults with duodenal ulcers caused by Helicobacter pylori (H. pylori) for the reduction of duodenal ulcer recurrence. Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the overall development program and clinical trial designs to support antimicrobial-containing H. pylori treatment regimens. This guidance intends to serve as a focus for continued discussions among the Division of Special Pathogen and Transplant Products, pharmaceutical sponsors, the academic community, and the public. As the science of this indication evolves, this guidance may be revised as new information accumulates.
Scope & Applicability
Product Classes
2Licensed under section 351 of the Public Health Service Act.
sponsors may wish to develop fixed-dose combination or co-packaged drug products
Stakeholders
4Entity responsible for submitting applications under section 524B
The investigator and the endoscopist should be blinded to treatment
The microbiologist should be blinded to treatment
professional who views the image on a computer monitor to arrive at a diagnosis
Regulatory Context
Attributes
4Sponsors should perform efficacy analyses on two specific populations: MITT and per-protocol
Measurement of treatment success against the pathogen
treatment effect of the active-comparator drug that can be reliably distinguished from placebo
Prespecified margin for comparing treatment difference
Identified Hazards
Hazards
1substances that may contribute to antimicrobial resistance
Related CFR Sections (2)
- 21CFR300.50§ 300.50 Fixed-combination prescription drugs for humans.
The Food and Drug Administration's policy in administering the new-drug, antibiotic, and other regulatory provisions of the Federal Food, Drug, and Cosmetic Act regarding fixed combination dosage form prescription drugs for humans is as follows:Read full regulation →
- 21CFR314.126§ 314.126 Adequate and well-controlled studies.
(a) The purpose of conducting clinical investigations of a drug is to distinguish the effect of a drug from other influences, such as spontaneous change in the course of the disease, placebo effect, or biased observation. The characteristics described in paragraph (b) of this section have been develRead full regulation →
See Also (8)
- How to Prepare a Pre-Request for Designation (Pre-RFD): Guidance for Industry (Status: Final)
- Development of New Stereoisomeric Drugs (Status: Final)
- Format and Content of the Clinical and Statistical Sections of an Application (Status: Final)
- Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms — Recommendations for Clinical Evaluation (Status: Draft)
- Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention (Status: Draft)
- Influenza: Developing Drugs for Treatment and/or Prophylaxis (Status: Final)
- Codevelopment of Two or More New Investigational Drugs for Use in Combination (Status: Final)
- Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment (Status: Draft)