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The following HTML text is provided to enhance online readability. Many aspects of typography translate only awkwardly to HTML. Please use the page image as the authoritative form to ensure accuracy. safety signal strengthening and testing, 110–115 speed of, 16 APPROVe trials, 55 Association of American Medical Colleges (AAMC), 142, 211 Automated healthcare databases, 7, 114–115 Azidothymidine (AZT), 37 B Bain report, 32 Best Pharmaceuticals for Children Act, 57, 152, 165 “Best practices,” disseminating, 87–88 Bias, intellectual, 141 Biologics license application (BLA) submissions, 42 numbers of new approvals, 42 Biotechnology Industry Organization (BIO), 88 Bioterrorism and Preparedness and Response Act, 23 BLA. See Biologics license application submissions Booz Allen Hamilton, 211 Boston Consulting Group, 123 British National Formulary, 170 Bromfenac, 38 Bureau of Labor Statistics, 92 Bush, President George W., 88, 207 C C-Path Institute, 213 Calcium-channel blockers, 115 Cardiovascular risks, 112, 116 CBER. See Center for Biologics Evaluation and Research CDC. See Centers for Disease Control and Prevention CDER. See Center for Drug Evaluation and Research CDRH. See Center for Devices and Radiological Health Celecoxib, 17 Center for Biologics Evaluation and Research (CBER), 49, 129, 188 Center for Devices and Radiological Health (CDRH), 188 Center for Drug Evaluation and Research (CDER), ix–x, 15, 21, 31, 46–47, 49, 65, 105, 179, 193–202, 205. See also Organizational dysfunction in the CDER culture; Solutions proposed for CDER’s organizational dysfunction credibility of, 85 history of funding, 194 IT needs within, 202 organizational culture in, 4, 66 press coverage of internal problems in, 2 recommendations concerning review teams, 10, 146–147 relevant changes at, 210 shepherding products through trials, 154 Center for Outcomes and Evidence, 212 Centers for Disease Control and Prevention (CDC), 81, 112, 128 Centers for Education and Research on Therapeutics (CERTs), 109 Centers for Medicare and Medicaid Services (CMS), 21, 25, 115, 180–181, 201 Central Hudson Gas & Electric Corp. v. Public Service Commission, 159–160 CERTs. See Centers for Education and Research on Therapeutics CFR. See Code of Federal Regulations Changes at the FDA during course of study, 205–215 Critical Path Initiative and partnerships, 212–213 Drug Safety Initiatives, 205 Drug Safety Oversight Board, 205–206 Drug Watch Web page, 206 labeling, 210 leadership changes in the FDA, 207–208 other relevant changes at the FDA and CDER, 210
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