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Reportlinker Adds The Clinical Trials Business
Date:12/14/2010

OD AND DRUG ADMINISTRATION (FDA) 16

Background 16

Center for Biologics Evaluation and Research (CBER) 17

CBER and Bioterrorism 18

Center for Drug Evaluation and Research (CDER) 18

CDER and Bioterrorism 18

Critical Path Initiative (CPI) 19

MEDICAL DEVICES 19

Center for Devices and Radiologic Health (CDRH) 19

Articles Subject to Medical Device Amendments 19

Classification of Devices (General Section 513) 20

• Class I—General Controls 20

• Class II—Special Controls 20

• Class III 21

Expedited Review 21

FIGURE 3 NEW DRUG DEVELOPMENT 21

TABLE 5 CDER APPROVAL TIMES FOR PRIORITY AND STANDARD NDAS AND BLAS, CALENDAR YEARS, 1993 2008 22

Expedited Development and Review 22

TABLE 6 FIRST CYCLE APPROVAL RATE FOR OVERALL STUDY COHORT BY YEAR, 2002-2007 23

Subpart E 23

Accelerated Approval (Subpart H) 24

Priority Review 24

Fast Track 24

TABLE 7 NUMBER AND TOTAL APPROVAL TIME (IN MONTHS) OF APPROVED NDAS AND BLAS, BY FISCAL YEAR OF SUBMISSION AND BY REVIEW PROCEDURE 25

Pediatrics 25

U.S. LITIGATION AND CLINICAL TRIALS 25

TABLE 8 INSURANCE COMPANIES OFFERING CLINICAL TRIAL LIABILITY INSURANCE 26

INVESTIGATIONAL REVIEW BOARD (IRB) 26

EUROPEAN REGULATIONS 27

JAPANESE REGULATIONS 28

GLOBAL REGULATORY STANDARDS 28

INTERNATIONAL CONFERENCE OF HARMONIZATION (ICH) 28

International Conference of Harmonization … (Continued) 29

Chapter-4: CLINICAL TRIAL COST AND FUNDING

MANAGING CLINICAL TRIALS 30

CONTRACT RESEARCH ORGANIZATIONS (CROS) 31

CLINICAL TRIAL RESEARCH THERAPEUTIC AREAS 31

FIGURE 4 PHRMA MEMBER R&D FUNDING BY THERAPEUTIC CATEGORY, 2010 (% SHARE) 32

TABLE 9 BEST-SELLING PHARMACEUTICAL DRUGS WORLDWIDE, 2009 ($ BILLIONS) 33

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