safety signal strengthening and testing, 110115

shortening, 107119

speed of, 16

APPROVe trials, 55

Association of American Medical Colleges (AAMC), 142, 211

Automated healthcare databases, 7, 114115

Azidothymidine (AZT), 37

B

Bain report, 32

Bayesian analysis, 109110

Best Pharmaceuticals for Children Act, 57, 152, 165

“Best practices,” disseminating, 8788

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

Black box warnings, 50, 5859

Black triangle, 170171

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, 4647, 49, 65, 105, 179, 193202, 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, 146147

relevant changes at, 210

shepherding products through trials, 154

staffing, 195, 199200

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, 180181, 201

Central Hudson Gas & Electric Corp. v. Public Service Commission, 159160

Cerivastatin, 17, 109

CERTs. See Centers for Education and Research on Therapeutics

CFR. See Code of Federal Regulations

Changes at the FDA

during course of study, 205215

Critical Path Initiative and partnerships, 212213

Drug Safety Initiatives, 205

Drug Safety Oversight Board, 205206

Drug Watch Web page, 206

labeling, 210

leadership changes in the FDA, 207208

other relevant changes at the FDA and CDER, 210

program reviews or evaluations, 211212



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