Description
The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of acute bacterial otitis media (ABOM). This guidance defines ABOM as “the recent or acute onset of inflammation of the middle ear caused by a bacterial pathogen.” Specifically, this guidance addresses the FDA’s current thinking regarding the overall development program and clinical trial designs for drugs to support an indication for treatment of ABOM.2
Scope & Applicability
Product Classes
1In case of investigational drugs, provide as much information as known.
Stakeholders
4Assist sponsors in the nonclinical evaluation
Subject population requiring special ethical protections.
Safety oversight body for interpreting adverse events; Safety oversight body for study design
It may be a hardship for patients and/or caregivers to attend in-person; Individuals who may assist patients or provide observations when patients cannot self-report.; conducted with caregivers to obtain similar feedback
Regulatory Context
Attributes
5Trial objective to show a drug is not significantly worse than a comparator
Primary efficacy endpoint defined by lack of improvement or complications.
Primary efficacy endpoint defined as resolution of diarrhea
Objective of showing response to intervention is superior to a comparator.
Justification essential for trials using a noninferiority design
Related CFR Sections (5)
- 21CFR312.32§ 312.32 IND safety reporting.
(a) Definitions. The following definitions of terms apply to this section:Read full regulation →
- 21CFR50.52§ 50.52 Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects.
Any clinical investigation within the scope described in §§ 50.1 and 56.101 of this chapter in which more than minimal risk to children is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely tRead full regulation →
- 21CFR56.111§ 56.111 Criteria for IRB approval of research.
(a) In order to approve research covered by these regulations the IRB shall determine that all of the following requirements are satisfied:Read full regulation →
- 21CFR50.53§ 50.53 Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition.
Any clinical investigation within the scope described in §§ 50.1 and 56.101 of this chapter in which more than minimal risk to children is presented by an intervention or procedure that does not hold out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is Read full regulation →
- 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 →
Related Warning Letters (10)
- 2025-09-09
Clinical Investigator
Shirish M. Gadgeel, M.D.
- 2025-07-15
Clinical Investigator
Mark J. Savant, M.D
- 2025-05-20
Bioresearch Monitoring Program/Institutional Review Board (IRB)
United Health Products, Inc.
- 2025-03-25
Clinical Investigator
Americo F. Padilla, M.D.
- 2024-11-05
Institutional Review Board (IRB)
Armstrong County Memorial Hospital
- 2024-10-22
Clinical Investigator
Namita A. Goyal, M.D.
- 2024-10-08
Institutional Review Board (IRB)
Louisiana State University Health Science Center IRB
- 2024-07-16
Bioresearch Monitoring Program/IRB
Massachusetts Institute of Technology MIT
- 2024-03-26
Institutional Review Board (IRB)
New York State Psychiatric Institute IRB
- 2023-06-06
Investigational Device Exemptions (Clinical Investigator)
Mobeen Mazhar, M.D.
See Also (8)
- Acute Bacterial Sinusitis — Developing Antimicrobial Drugs for Treatment (Status: Final)
- Use of Data Monitoring Committees in Clinical Trials (Status: Draft)
- Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations: Draft Guidance for Industry (Status: Draft)
- Process for Handling Referrals to FDA Under 21 CFR 50.54 - Additional Safeguards for Children in Clinical Investigations: Guidance for Clinical Investigators, Institutional Review Boards and Sponsors (Status: Final)
- Exception from Informed Consent Requirements for Emergency Research: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors (Status: Final)
- Premarket Assessment of Pediatric Medical Devices: Guidance for Industry and FDA Staff (Status: Final)
- Vaginal Microbicides:Development for the Prevention of HIV Infection PDF (Status: Final)
- Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products: Guidance for Industry (Status: Final)