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# Final Smallpox Drug Development Guide Posted
- URL: https://www.fdaweb.com/final-smallpox-drug-development-guide-posted/
- Published: 2019-11-18T12:00:00.000Z
- Updated: 2026-09-14T15:53:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145524

FDA has issued a [final guidance](https://www.fda.gov/media/132623/download?ref=fdaweb.com) entitled “Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention.” The document is intended to serve as a focus for continued discussions among the Division of Antiviral Products, pharmaceutical sponsors, the academic community, and the public. It focuses on drugs that are expected to inhibit variola virus replication. Although antiviral drugs are its primary focus, the guidance says that therapeutic proteins or monoclonal antibodies also may be eligible for evaluation under the Animal Rule. “Sponsors interested in developing small molecules, therapeutic proteins, or monoclonal antibodies for use against smallpox are encouraged to discuss their approach with the FDA as early as possible in development and to communicate with the FDA through the Pre-IND Consultation Program,” it says.