Description
The purpose of this guidance is to assist sponsors in the clinical development of drugs for treatment or prevention of smallpox (variola virus) infection. Clinical efficacy trials of drugs for treating or preventing smallpox are not feasible and challenge studies in healthy subjects are unethical; therefore, drugs for these indications should be developed and approved under the regulations commonly referred to as the Animal Rule (21 CFR part 314, subpart I, for drugs and 21 CFR part 601, subpart H, for biologics). This guidance serves as a focus for continued discussions among the Division of Antiviral Products (DAVP), pharmaceutical sponsors, the academic community, and the public.
Scope & Applicability
Product Classes
3Circumstance where a mass balance study might not be recommended
Vaccine used in postevent vaccination programs and for laboratory personnel
Proteins that reduce proinflammatory cytokines and affect CYP enzyme expression
Stakeholders
4Entity responsible for submitting applications under section 524B
Individuals at risk for occupational exposure
Provides recommendations for universal Hepatitis B vaccination
Met in 2011 to discuss variola virus infection drug development
Regulatory Context
Attributes
2CMC changes after tentative approval; shelf-life period supported by stability data; proposing to extend the expiration dating period for the drug product
Primary endpoint for efficacy studies
Identified Hazards
Hazards
3Potential use of variola virus as a weapon
Safety finding requiring reporting; Reports of occupational exposure should be followed up
Risk associated with small molecule inhibitors like nucleoside analogues
See Also (8)
- 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)
- Nuclear Pharmacy Guideline Criteria for Determining When to Register as a Drug Establishment (Status: Final)
- Women and Minorities Guidance Requirements (Status: Final)
- Levothyroxine Sodium Products Enforcement of August 14, 2001 Compliance Date and Submission of New Applications (Status: Final)