Generic drug reviews
Executive Summary
FDA plans to review 90% of ANDAs within six months as part of its fiscal year 2004 Performance Plan, a 10% increase over the agency's 2003 goal. "We plan to improve the review of ANDAs without sacrificing product quality to allow the agency to reach its goal of reviewing 80% of ANDAs in FY 2003 and 90% in FY 2004 within six months after submission," the agency's 1website states. The plan also includes a goal to review 55% of 630 high-risk manufacturers in fiscal year 2004...