Fast-track programs

Fast track program This program was added under the FDA Modernization Act of1997 as an extension of the accelerated drug and biologic product approval process. It was designed to facilitate development and expedite review for products that demonstrate potential or unmet medical needs in the treatment of serious or life-threatening conditions. 

Fast Track—Fast-track programs are designed to facilitate the development and expedite the review of new drugs or biologies that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. For additional information, go to http //www.fda.gov/cder/guidance/5645fnl.htm. 

Fast reactors, 17 568 Fast relaxation time, 24 127 Fast Track Drug Approval programs,... 

FDA Center for Food Safety and Applied Nutrition (CFSAN), 23 667 FDA certified colors, 12 35 FDA Fast Track Drug Approval programs, 18 697... 

After 5 years in the FDA s fast track development program, Romidepsin (Fig. 18) was approved by the FDA for refractory cutaneous T-cell lymphoma on November 6,2009. In the literature, romidepsin has also been called depsipeptide, FK228, FR901228, and NSC-630176. It was isolated from bacterial fermentation extracts from Chromobacterium violaceum and is a potent inhibitor of HDAC. In some human cancer cell lines, romidepsin inhibits HDACs at levels ten times that of TSA. 

Fast Track Drug Development Programs Designation, Development, and Application Review, Nov. 18,1998. 

A local person was appointment as the shadow manager for the SHE department and was placed on a fast-track development program to take over for the SHE manager within a year in an effort to develop and promote local talent. Two safety trainees were selected and appointed as safety apprentices and put on a 2-year developmait program leading up to the position of safety coordinator. The first Arab female safety trainee was appointed. 

The work is supported by the Department of Science and Technology (DST)— IRHPA Research Project (M. L. and V. K. C.) and a DST Ramanna Fellowship program. J. H. Sheeba is supported by a DST-FAST TRACK Young Scientist Research Project. M. Lakshmanan is supported by a DAE Raja Ramanna Fellowship Program. 

Individual facilities, companies, and industry associations must work with EPA, state, and local air pollution control agencies on the Title V program and regulations. Permit streamlining processes for major permits must be developed, together with fast-track approaches for minor equipment, chemical, and process changes. Time really is of the essence in this area. 

Direct the establishment and conduct of a mandatory, fast-track, standardized training program in fundamentals of DOE oversight, including the conduct of operations, for DOE program managers and field staff. 

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