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Safeguarding against Ebola: Vaccines and therapeutics to be stockpiled for future outbreaks
During the international response to the outbreak, numerous organizations, institutions, and international governments contributed to the evaluation of these medical countermeasures in the field, including the Ministries of Health in Guinea and Liberia, the Ministry of Health and Sanitation in Sierra Leone, the World Health Organization, and the Wellcome Trust, United Kingdom, to name a few.
Approval of Raxibacumab for the Treatment of Inhalation Anthrax Under the US Food and Drug Administration “Animal Rule”
The developmental process required for approval of Raxibacumab illustrates many of the challenges that product developers may encounter when pursuing approval under the Animal Rule and highlights a number of important regulatory and policy issues.