Emerging Viral Infections - Information for Industry
In addition to diseases such as HIV/AIDS, herpesvirus infections, and viral hepatitis, the Division of Antiviral Products reviews submissions and applications for antiviral products (including antiviral drugs and certain types of biologic products) directed against a range of infections that have recently emerged or re-emerged, or could emerge under certain conditions of public health crisis, as major causes of human illness. This category of emerging viral infections includes (but is not limited to) the following:
- Infections that may spread widely due to genetic changes in existing viral pathogens (such as novel strains of influenza);
- Infections appearing in new settings due to movement of human populations or of animal reservoirs (such as West Nile virus or monkeypox);
- Infections newly recognized as causes of human disease (such as SARS or hantavirus pulmonary syndrome);
- Infections that are rare or nonexistent under normal circumstances but that could be sources of significant concern in the context of potential bioterrorism/biowarfare threats (such as smallpox, serious vaccinia infections complicating smallpox vaccination, or certain viral hemorrhagic fevers).
Approaches to drug development for emerging viral infections
Development of drugs for emerging viral infections poses distinctive challenges because many of these illnesses are rare but may be life-threatening, and have the potential to change rapidly in incidence and/or virulence, such that a serious public health threat could arise with little advance opportunity for study. Thus, although developing treatment and control measures is a high priority, the traditional sequence of nonclinical and clinical studies may be very difficult to implement. In order to facilitate progress without compromising scientific standards, careful attention to the following possible approaches may be desirable. Prospective sponsors should discuss these with the review division:
- Consideration of potential applicability to emerging infections during development of antivirals for other purposes;
- Assembly and analysis of treatment experience for related products and diseases that may have indirect relevance to the product and disease of interest;
- Prospective design of nonclinical studies (including shared discussion of planned animal studies across all review disciplines) to provide as much supplemental information as possible in support of potentially limited clinical data;
- Prospective design of clinical trials to maximize the amount of useful information that may be gained from sparse experience, and to address both the importance of adequately controlled and monitored trials and the constraints of study conduct under emergency conditions;
- Regulatory mechanisms for facilitation of timely interactions.
Sponsors seeking to develop antiviral drugs for emerging infections are urged to communicate with the Division as early in the development process as possible. Typically the Pre-IND consultation program will provide an appropriate mechanism for such early consultations. For some drug development programs for emerging infections, repeated Pre-IND interactions may be desirable.
Selected FDA links for general information related to emerging viral infections and drug development
The following links provide access to additional FDA information on several of the general issues related to emerging viral infections and drug development for such infections.
Pre-IND Consultation Contact List(PDF - 27KB)
Potential sponsors or investigators are encouraged to contact the DAVP pre-IND contact with questions.
Pre-IND Consultation Program
Sponsors are urged to contact DAVP early in the development process to discuss the most efficient design and potential uses of nonclinical as well as clinical studies.
Influenza (Flu) Antiviral Drugs and Related Information
This site provides summaries and links to information regarding influenza control public health measures, pandemic influenza preparedness, and approved drugs for treatment and prevention of influenza.
Counterterrorism and Emerging Threats
This site provides links to general information on counterterrorism-related activities at FDA.
Selected FDA regulations, guidance, announcements/notices, and policy
The following are selected FDA regulations, guidance, announcements/notices, and policy related to facilitating development of and access to drugs for serious life-threatening infections with limited therapeutic options, including (but not limited to) potential threat agents. Relevance of the listed resources will vary for specific development proposals.
Final Rule: Expanded Access to Investigational Drugs for Treatment Use 21 CFR 312 Subpart E (312.80-312.88), Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses Emergency Use Authorization of Medical Products Vaccinia Virus — Developing Drugs to Mitigate Complications from Smallpox Vaccination(PDF - 139KB) Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention(PDF - 242KB) Influenza: Developing Drugs for Treatment and/or Prophylaxis(PDF - 417KB) Review Classification Policy: Priority (P) and Standard (S)(PDF - 75KB) 21 CFR 314 Subpart H (314.500-314.560), Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses 21 CFR 314 Subpart I (314.600-314.650), Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible (“Animal Rule”) 21 CFR 601 Subpart H (601.90-601.95), Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible (“Animal Rule” for biologic products) Animal Models — Essential Elements to Address Efficacy Under the Animal Rule_09(PDF - 135KB) Qualification Process for Drug Development Tools(PDF - 190KB) Fast Track Drug Development Programs - Designation, Development, and Application Review_PRA(PDF - 134KB) Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination(PDF - 94KB)
Additional links for general information on emerging infections and/or antiviral drug testing
The following links to non-FDA sites are provided for informational purposes.
Centers for Disease Control and Prevention Emerging Infectious Diseases
This site contains information and additional links for a range of emerging infections and related topics.
World Health Organization: Emerging Infections
This site contains links to information about emerging and re-emerging diseases and epidemic and pandemic alerts.
National Institute of Allergy and Infectious Diseases: Emerging and Re-Emerging Infectious Diseases National Institutes of Allergy and Infectious Diseases: Viral Infections
Sponsors of antiviral drugs that might have applicability to treatment of emerging viral infections can use the contact information at this site to discuss screening drugs for antiviral activity against emerging pathogens.
This site is a registry of clinical trials, searchable by categories such as disease and proposed intervention.