Description
The purpose of this guidance is to assist sponsors in the development of drugs for the treatment and/or prophylaxis of illness caused by influenza viruses A and B, including both seasonal and pandemic varieties. Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the overall development program and designs of clinical trials and nonclinical studies to support the development of influenza drug products.
Scope & Applicability
Product Classes
10Approved drugs for RHL treatment
Guidance on Antiviral Product Development
Validation of certain in vitro diagnostic devices (IVDs) for emerging pathogens; Validation of certain IVD devices for emerging pathogens
Clinical Data Needed to Support the Licensure
Include samples from both women and men at validation stages
Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
Approved antiviral drugs for influenza fall into two classes, neuraminidase inhibitors and the adamantanes
Approved antiviral drugs for influenza fall into two classes, neuraminidase inhibitors and the adamantanes
antiviral drugs have shown the ability to modestly reduce symptoms
Drug product containing multiple active ingredients
Stakeholders
2Entity responsible for submitting applications under section 524B
Resource for applicants regarding combination products
Regulatory Context
Attributes
6quantitative measurements of viral shedding in nasal washes
labeling issues related to stockpiled drugs
achieve the desired test sensitivity and specificity
A performance metric for the AI model
determines which center regulates a combination product
Microbiological outcome reasonably likely to predict clinical benefit
Identified Hazards
Hazards
1risk associated with antiviral use and selection pressure
Related CFR Sections (4)
- 21CFR312.62§ 312.62 Investigator recordkeeping and record retention.
(a) Disposition of drug. An investigator is required to maintain adequate records of the disposition of the drug, including dates, quantity, and use by subjects. If the investigation is terminated, suspended, discontinued, or completed, the investigator shall return the unused supplies of the drug tRead 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 →
- 21CFR312.120§ 312.120 Foreign clinical studies not conducted under an IND.
(a) Acceptance of studies.Read full regulation →
- 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 →
Related Warning Letters (4)
- 2025-12-23
In Vivo Bioavailability-Bioequivalence Studies – Clinical
Maria A. Carballosa, M.D.
- 2025-03-18
Clinical Investigator
Mehran Michael Bahrami, M.D.
- 2024-08-13
Bioresearch Monitoring Program/IRB
Konrad Rejdak, M.D., Ph.D.
- 2022-01-04
Bioresearch Monitoring Program/IRB
Vasyl Melnyk, M.D.
See Also (8)
- Special Protocol Assessment Guidance for Industry (Status: Final)
- Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention Guidance for Industry (Status: Final)
- Internal Radioactive Contamination —Development of Decorporation Agents (Status: Final)
- ANDA Submissions – Prior Approval Supplements Under GDUFA: Guidance for Industry (Status: Final)
- CPG Sec. 400.210, Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs (Status: Final)
- Format and Content of the Microbiology Section of an Application*: Guidance for Industry (Status: Final)
- Formatting, Assembling and Submitting New Drug and Antibiotic Applications* (Status: Final)
- Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application (Status: Final)