FDA Grants Fast Track Designation to DVC Biodefense Vaccine Development Programs
PR Newswire
EL SEGUNDO, Calif., Sept. 14 /PRNewswire-FirstCall/ -- Computer Sciences Corporation (NYSE: CSC - News) today announced that DVC LLC, a CSC company, has received Fast Track designation status from the U.S. Food and Drug Administration (FDA) for three biodefense vaccine development programs it is working on for the Department of Defense Joint Vaccine Acquisition Program (JVAP) Product Management Office.
DVC programs to develop recombinant vaccines for plague and botulinum neurotoxin serotypes A and B, and the company's program to develop a live, attenuated vaccine for Venezuelan equine encephalitis have received the Fast Track designation. Fast Track status allows the FDA to expedite review of drugs and biologics that demonstrate the potential to address unmet medical needs and are intended to treat serious or life-threatening conditions.
"At DVC, our mission is to expedite the development of biodefense products to protect the nation's operating forces and citizens," said DVC Chief Scientific Officer Dr. Robert V. House. "We do this by applying for Fast Track status, which enables us to work closely with the FDA to more efficiently meet military biodefense needs."
JVAP's mission is to develop, produce and stockpile FDA-licensed vaccine products to protect the warfighter against biological warfare agents. JVAP consolidates Department of Defense efforts for the advanced development, testing, FDA licensing, production and storage of biological defense vaccines.
DVC is a biodefense company dedicated to the development and licensure of safe and efficacious biological products. DVC is part of CSC's Enforcement, Security and Intelligence organization, which CSC created in 2001 to support programs enhancing U.S. security.
The safety and efficacy of these vaccines in humans has not been established. These products are currently under clinical investigation and have not been licensed by the FDA.
EL SEGUNDO, Calif., Sept. 14 /PRNewswire-FirstCall/ -- Computer Sciences Corporation (NYSE: CSC - News) today announced that DVC LLC, a CSC company, has received Fast Track designation status from the U.S. Food and Drug Administration (FDA) for three biodefense vaccine development programs it is working on for the Department of Defense Joint Vaccine Acquisition Program (JVAP) Product Management Office.
DVC programs to develop recombinant vaccines for plague and botulinum neurotoxin serotypes A and B, and the company's program to develop a live, attenuated vaccine for Venezuelan equine encephalitis have received the Fast Track designation. Fast Track status allows the FDA to expedite review of drugs and biologics that demonstrate the potential to address unmet medical needs and are intended to treat serious or life-threatening conditions.
"At DVC, our mission is to expedite the development of biodefense products to protect the nation's operating forces and citizens," said DVC Chief Scientific Officer Dr. Robert V. House. "We do this by applying for Fast Track status, which enables us to work closely with the FDA to more efficiently meet military biodefense needs."
JVAP's mission is to develop, produce and stockpile FDA-licensed vaccine products to protect the warfighter against biological warfare agents. JVAP consolidates Department of Defense efforts for the advanced development, testing, FDA licensing, production and storage of biological defense vaccines.
DVC is a biodefense company dedicated to the development and licensure of safe and efficacious biological products. DVC is part of CSC's Enforcement, Security and Intelligence organization, which CSC created in 2001 to support programs enhancing U.S. security.
The safety and efficacy of these vaccines in humans has not been established. These products are currently under clinical investigation and have not been licensed by the FDA.
