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Bedaquiline Receives Accelerated Approval from the FDA for MDR-TB Rx
The FDA granted Janssen’s TB drug Bedaquiline accelerated approval for treatment of MDR-TB. A link is provided to the FDA press release and Janssen’s full press release is included.
FDA Advisory Committee recommends Janssen’s Bedaquiline for accelerated approval
Yesterday, Nov. 28th, the FDA Ant-infective Drug Advisory Committee voted to recommend Janssen’s Bedaquiline for accelerated approval for the treatment of MDR tuberculosis. A summary of the proceedings is included.
Launch of the Good Participatory Practice Guidelines for TB Drug Trials
The Stakeholder and Community Engagement Workgroup of the Critical Path to TB Drug Regimens initiative launches guidelines that will facilitate the involvement of communities and participants in the conduct of TB drug trials.
Posted in Regulations and Guidelines, TB Prevention and Control Strategies, TB Treatment
Updated WHO guidelines on Drug-Resistant TB
The WHO issued updated guidelines on the programmatic management of drug-resistant TB on August 4, 2011 online in the European Respiratory Journal.
Posted in Regulations and Guidelines, TB Drug Development, TB Prevention and Control Strategies, TB Treatment
TB R&D Weekly Update: Promoting Fixed-dose Combos for TB control
In this week’s article, Monedero and Caminero conduct a critical review of research on the use of fixed-dosed combinations (FDCs) for tuberculosis with the conclusion that FDCs should continue to be promoted and recommended. Additional links to TB R&D News are included.
Posted in Announcements, Regulations and Guidelines, TB Prevention and Control Strategies, TB Treatment
New Report on Drugs for Drug-resistant TB
The Médecins Sans Frontières and The Union will release on World TB Day a new report entitled “DR-TB drugs under the microscope” outlining drugs currently available to treat drug-resistant tuberculosis (DR-TB) including product information, sources of the drug, quality status, and price.
FDA Streamlines Review for Drug Combinations
The FDA issued a draft guidance for the drug industry entitled “Guidance for Industry Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination.”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.
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You are currently browsing the archives for the Regulations and Guidelines category.
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Toppix TB News- Detection of second-line drug resistance in mycobacterium... 24 May 2013
- Effect of Isoniazid Shortage on TB Care 24 May 2013
- Shortage of Key Drug Hampering U.S. Efforts to Control TB: Report 23 May 2013
- Impact of a Shortage of First-Line Antituberculosis Medication on... 23 May 2013
- TB, a neglected disease in Uganda 15 May 2013
