During the “Cure All: A briefing on the status of the most promising new TB drugs research” sponsored by the Critical Path to New TB Drug Regimens (CPTR) on Monday, March 19, Dr. Mel Spigelman, CEO & President, of TB Alliance announced the launch of the NC002 trial, a combination drug trial that establishes a new pathway to TB and multi-drug resistant TB treatment. The meeting also involved high-level officials from U.S. agencies that support TB research including Anthony Fauci (Director, NIAID/NIH), Janet Woodcock (Director, CDER/FDA), and Robert Clay (Deputy Assistant Administrator, Global Health Bureau/USAID).
The FDA issued a draft guidance for the drug industry entitled “Guidance for Industry Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination.” This is exciting news for TB drug development, since there is the potential to reduce the time to develop and obtain approval for new regimens by several years. The FDA is accepting comments from the public until February 14, 2011.
The U.S. Food and Drug Administration (FDA) announced $2.9 million to support six research projects related to the diagnosis, treatment and prevention of tuberculosis on Monday. This investment is a component of the FDA’s Critical Path Initiative (CPI) — a national strategy for transforming the way FDA-regulated products are developed, evaluated and manufactured.