Cannabis Science Inc (fka CBIS)

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Fast Track, Accelerated Approval and Priority
Review are approaches that are intended to make therapeutically
important drugs available at an earlier time.


FDA can approve in as little as 3 Months


They do not compromise the standards for the safety and
effectiveness of the drugs that become available through this
process.

These revitalized FDA drug review approaches have yielded tangible results in bringing safe and effective drugs to patients with serious diseases more quickly. For example, since 1996, 68 drugs for cancer therapies have received priority review and approval.

FDA reviewed Gleevec, a treatment for chronic myeloid leukemia, in four months. Shortened review times have also brought promising treatments to patients with HIV/AIDS more quickly. Kaletra for the treatment of HIV/AIDS was reviewed and approved in 3.5 months. Pegasys, a combination product for the treatment of Hepatitis C was approved for marketing in 4 months.

The table below illustrates the improvement in FDA review times in the years between 1993 to 2003. The median time required to review a priority review drug was reduced from 13.9 months to 6.7 months.

Fast Track, Accelerated Approval, and Priority Review have evolved over time. FDA has been vigilant in assuring that reducing the time necessary for drug development has not compromised the safety and effectiveness of drugs for patients with serious diseases.