FDA issues final guidance for development of smallpox treatments as part of critical preparedness efforts
The U.S. Food and Drug Administration today issued final guidance, Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention , which is designed to assist drug manufacturers designing studies to appropriately establish the safety and efficacy of drugs to treat or prevent smallpox infection.
Although smallpox was declared eradicated in 1980, concerns exist that it could remain in unknown locations or used as a biological weapon. Routine smallpox vaccination in the U.S. was discontinued in the 1970s, and because there is no natural disease exposure, most of the U.S. lacks immunity to smallpox, which leaves the population particularly vulnerable. Because of the unique complexities of drug development in this area, the FDA has been involved in extensive discussions with multiple stakeholders, including a public workshop in 2009 and an Advisory Committee meeting in 2011, which helped formulate the regulatory pathway for smallpox drug development described in this guidance. This guidance finalizes draft guidance issued on July 11, 2018, which revised draft guidance issued on November 23, 2007. This final guidance clarifies the recommended immunological characterization of animals in key studies and includes minor editorial changes from the draft.
The FDA plays a critical role in protecting the U.S. from chemical, biological, radiological, nuclear and emerging infectious disease threats, including facilitating the development of safe and effective medical countermeasures to diagnose, treat and prevent deadly infections, developing guidance for industry, holding Advisory Committee meetings to discuss medical product development, monitoring for fraudulent products and false product claims and taking appropriate action to protect consumers.
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