FDA's MCMi makes progress in 2012
In 2010, MCMi received one-time funding of $170 million from the Department of Health and Human Services to immediately start countermeasure-related activities. The initiative received an additional appropriation of $20.038 million from Congress in 2012.
Through the initiative, the FDA was able to approve multiple medical products to counter CBRN agents and emerging threats of infectious disease.
In late April, the FDA approved Levaquin for the treatment of plague in adults and patients six months of age and older. The drug was approved through the animal rule, allowing a medicine to be approved based on animal studies when it is not feasible to conduct human clinical trials, MedCityNews.com reports.
The FDA also cleared nine influenza diagnostic 510(k) submissions and granted clinical laboratory improvement amendment waivers for three influenza devices.
Additionally, the agency continued to work with partners to make sure that the U.S. is prepared to deploy medical countermeasures from the Strategic National Stockpile. The agency completed the review of the pre-emergency use authorization package for the Modified Vaccinia Ankara smallpox vaccine and final reviews for six high-priority pre-EUA packages for Department of Defense diagnostic biothreat detection devices.