Word: fda
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...three-point plan, designed to aid the rapidly developing field, will greatly expedite the review and approval of new products, according to FDA Commissioner Dr. David Kessler...
...plan, which was discussed at the monthly meeting of the Massachusetts Biotechnology Council in Boston, focuses on improving and accelerating the FDA approval process so that drugs will become available to consumers more quickly...
...young, start-up, single product company, the time taken up by the FDA review process can mean the difference between success and failure," said Kessler in a speech to the council last Thursday...
...most significant provision of Kessler's plan is the creation of 50 additional FDA research and review staff positions. These new employees will work exclusively on evaluating biotechnology products...
...addition to the appointments, the FDA will establish a collaborative working agreement between the Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research, two federal agencies which oversee the drug approval process...