2011 Pharmaceuticals Research Review
BCC Research
January 1, 2012 214 Pages - SKU: WA6727313
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Countries covered: Global
The global market for marine-derived drugs by type was around $4.8 billion in 2011, which is expected to be around $5.3 billion in 2012. This global market is forecasted to reach $8.6 billion by 2016 at a compound annual growth rate (CAGR) of 12.5% for the five year period of 2011 to 2016.
The overall emerging markets for therapeutic drugs totaled $131.4 billion in 2009. These regions include Latin America, China, Eastern Europe, the Middle East, South Korea, India, Russia, and South Africa. These regions are estimated at $145.8 billion in 2010 and expected to continue aggressive growth through 2015, reaching a figure of $214.2 billion, yielding a compound annual growth rate (CAGR) of 8% from 2010 to 2015.
The global market for blood-brain barrier (BBB) technology for therapeutics amounted to $12.3 million in 2010 and will reach $387 million by 2015, a compound annual growth rate (CAGR) of 99.3%.
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Additional InformationFOREWARD
The pharmaceutical industry continues to twist and turn toward the sunlight, and away from the darkness of the patent cliff. As growth rates slow, alarm is never far from the lips. Purchasing power within middle-income families in BRIC countries (Brazil, Russia, India, and China) is often described as being just what the doctor ordered, but in truth “blockbuster” means something far smaller here, while affordability and IP issues become more pressing.
Some companies pursue new classes of therapy by exploring ways to enter the blood brain barrier with specialized formulations or procedures, which may reawaken the concept of lifestyle drugs. Others keep the light burning by looking for ways to deliver RNAi and stem cell therapies. Still others dredge the vast oceans for novel chemical entities. Ultimately, innovation is the only sure cure for stalled sales.
BCC Research has provided comprehensive coverage of pharmaceutical markets for many years, and we are now increasing our coverage of global pharmaceutical markets. This review of pharmaceutical market research conducted in 2011 is meant to provide a sampling of the type of quantitative market information, analysis and guidance that has been aiding business decision-making since BCC was founded in 1971.
- 2011 PHARMACEUTICALS RESEARCH REVIEW
- FOREWORD
- CHAPTER ONE: GLOBAL MARKETS FOR MARINE-DERIVED
- PHARMACEUTICALS (PHM101A)
- INTRODUCTION
- STUDY GOALS AND OBJECTIVES
- REASONS FOR DOING THIS STUDY
- SCOPE OF REPORT
- INTENDED AUDIENCE
- METHODOLOGY
- INFORMATION SOURCES
- ABOUT THE AUTHOR
- RELATED BCC REPORTS
- BCC ONLINE SERVICES
- DISCLAIMER
- EXECUTIVE SUMMARY
- TABLE 1 GLOBAL FORECAST FOR MARINE-DERIVED DRUGS BY TYPE, THROUGH 2016 ($ MILLIONS)
- FIGURE 1 GLOBAL FORECAST FOR MARINE-DERIVED DRUGS, 2010-2016 ($ MILLIONS)
- INVESTMENT AND PATH FORWARD
- KEY DRIVERS
- KEY CHALLENGES
- KEY TRENDS
- DEVELOPMENT OF MICROBES SYMBIOTIC WITH MARINE INVERTEBRATES
- USE OF ALGAE IN NOVEL WAYS
- GREATER USE OF ESTABLISHED MARINE LIFE LIBRARIES
- CONTINUED FOCUS ON CANCER
- EXPANSION OF KNOWLEDGE AND USE OF CONOPEPTIDES
- IMMUNE CELL INDUCEMENT THERAPY
- INVESTMENT LANDSCAPE
- KEY INVESTMENTS/COLLABORATIONS IN MARINE-DERIVED DRUG DEVELOPMENT
- Abbott Laboratories and Seattle Genetics
- Algenics, IFREMER, Roquette Group
- Aphios Corp., Novartis, Bayer, Bristol-Myers Squibb, Eli Lilly, Baxter Healthcare, Sigma-Aldrich
- Aquapharm Biodiscovery, Ltd. and Albany Molecular Research Group
- ArcticZymes, Universities in Tromsø, Trondheim (NTNU/Norway), and Umeå (Sweden)
- ASKA and Yakult Honsha
- AstraZeneca (MedImmune) and Xenome
- Azur Pharma and Eisai
- Boehringer Ingelheim, Sigma-Tau, Pacira
- Cognetix, Inc. and the University of Utah
- Genzyme and Abbott Laboratories
- Gilead Sciences, Inc. and UC Santa Cruz
- GlaxoSmithKline and Pfizer
- GlaxoSmithKline/Pronova, Affiris, and Stellar Biotechnologies
- GlycoMar and Verona Pharma
- Johnson & Johnson, PharmaMar, and Taiho Pharmaceuticals
- National Cancer Institute and Bristol-Myers Squibb
- Nautilus Biosciences Canada, Inc. and the NRC-INH on the Campus of UPEI
- Scripps Institution of Oceanography, Trius Therapeutics, and Nereus Pharmaceuticals
- Seattle Genetics, Astellas, CellDex, Millennium
- Stellar Biotechnologies, Bayer Innovation, Amgen, Merck, Biovest, Néovacs, Affiris, GlaxoSmithKline
- Triton Biopharma, University of Mississippi, PharmaMar
- OVERVIEW
- HISTORY OF MARINE DRUGS
- TABLE 2 KEY DATES IN MARINE-DERIVED DRUG HISTORY
- TABLE 3 GROWTH IN THE INTEREST IN MARINE NATURAL PRODUCTS BASED ON THE NUMBER OF PRODUCTS DESCRIBED IN SCIENTIFIC JOURNALS, 1999-2004
- MAJOR CATEGORIES OF MARINE DRUGS
- Main Chemical Classes
- Phenols
- Steroids
- Ether
- Strigolactones
- Peptides
- Main Marine Life Groupings
- Marine Microorganisms
- Marine Algae
- Marine Invertebrates
- • Porifera
- • Discodermolide
- • Cnidarians
- • Ctenophora
- • Bryozoa
- • Mollusca
- • Echinoderms
- • Protozoa
- • Chordates
- FIGURE 2 THE TUNICATE ECTEINASCIDIA TURBINATE FROM WHICH YONDELIS (TRABECTEDIN) FOR CANCER TREATMENT IS MADE
- FIGURE 3 MARINE SPECIES PER PHYLUM BASED ON WORMS
- FIGURE 4 APPROXIMATION OF KNOWN VERSUS POSSIBLE SPECIES WITHIN THREE PHYLA, 2011
- CHAPTER TWO: EMERGING REGIONAL MARKETS FOR THERAPEUTIC DRUGS (PHM076A)
- INTRODUCTION
- STUDY GOALS AND OBJECTIVES
- REASONS FOR DOING THE STUDY
- SCOPE OF REPORT
- INTENDED AUDIENCE
- METHODOLOGY AND INFORMATION SOURCES
- ANALYST CREDENTIALS
- RELATED BCC REPORTS
- SUMMARY
- TABLE 4 TOTAL EMERGING GEOGRAPHIC MARKETS BY REGION, THROUGH 2015 ($ MILLIONS)
- FIGURE 5 TOTAL EMERGING GEOGRAPHIC MARKETS, BY REGION, 2007-2015 ($ MILLIONS)
- OVERVIEW
- TABLE 5 ECONOMIC STATISTICS AND GROSS DOMESTIC PRODUCTION FOR EMERGING COUNTRIES, 2008 ($ BILLIONS/%)
- EMERGING MARKET OPPORTUNITIES
- EMERGING MARKET CHALLENGES
- CHAPTER THREE: BLOOD-BRAIN BARRIER TECHNOLOGIES AND GLOBAL MARKETS (PHM075A)
- INTRODUCTION
- STUDY GOALS AND OBJECTIVES
- REASONS FOR DOING THIS STUDY
- SCOPE OF REPORT
- INTENDED AUDIENCE
- METHODOLOGY
- INFORMATION SOURCES
- ABOUT THE AUTHOR
- RELATED BCC REPORTS
- EXECUTIVE SUMMARY
- EMERGING BBB TECHNOLOGY MARKET
- KEY DRIVERS
- KEY CHALLENGES
- MAJOR TRENDS
- TABLE 6 GLOBAL MARKET FOR BBB TECHNOLOGY FOR THERAPEUTICS, THROUGH 2015 ($ MILLIONS)
- FIGURE 6 GLOBAL MARKET FOR BBB TECHNOLOGY FOR THERAPEUTICS, THROUGH 2015 ($ MILLIONS)
- OVERVIEW
- TODAY’S PHARMA MARKET
- FIGURE 7 GEOGRAPHIC DISTRIBUTION OF PHARMACEUTICAL DRUGS BY REGION, 2009 AND 2015 (% OF GLOBAL SALES)
- FIGURE 8 EMERGING MARKETS’ GROWTH IN PHARMACEUTICAL SALES, 2015 (ESTIMATED $ BILLIONS)
- FIGURE 9 GLOBAL MARKET FOR BBB TECHNOLOGY FOR THERAPEUTICS BY REGION, 2015* ($ MILLIONS)
- BIOLOGICS
- FIGURE 10 INVESTMENT IN BIOLOGICS AS A PERCENTAGE OF TOTAL R&D, 2009 (% OF TOTAL R&D)
- GENERICS SIGNAL NEED FOR INNOVATION
- NEUROFOCUSING IN THE PHARMA INDUSTRY
- FIGURE 11 CNS REVENUE DISTRIBUTION BY DISEASE TARGET, 2009 ($ BILLIONS)
- FIGURE 12 GLOBAL MARKET FOR BBB TECHNOLOGY FOR THERAPEUTICS, 2015 AND 2017 (NUMBER OF UNITS)
- FIGURE 13 GLOBAL MARKET FOR BBB TECHNOLOGY FOR THERAPEUTICS BY INDICATION, 2015 AND 2017 (NUMBER OF UNITS PER INDICATION)
- TABLE 7 TOP PHARMA COMPANIES BY REVENUE, 2009 ($ BILLIONS)
- EMERGING BBB TECHNOLOGY MARKET
- BRIEF HISTORY OF BBB
- BLOOD BRAIN BARRIER DEFINED
- BBB COMPONENTS
- FIGURE 14 PARTS OF THE BBB
- BBB ILLUSTRATED
- MAIN AREAS OF THE BRAIN
- FIGURE 15 THE BRAIN: BBB PROTECTS AND BRIDGES IT TO BLOOD VESSELS
- TREATING DISEASE AND THE BBB
- MENINGITIS
- MULTIPLE SCLEROSIS (MS)
- ENCEPHALITIS
- ALZHEIMER’S DISEASE (AD)
- PARKINSON’S DISEASE (PD)
- BBB TECHNOLOGY CLASSIFICATION
- MOST COMMON BBB TECHNOLOGY
- CHALLENGES WITH THE MOST COMMON TECHNOLOGY USED
- TRANSPORT CONSIDERATIONS
- BYPASSING THE BBB
- BBB TECHNOLOGY DETAILED
- CHEMICAL TRANSPORT SYSTEMS
- BIOLOGICAL CARRIER OR TRANSPORT SYSTEMS
- PHYSICAL FORCE (ENERGETIC) OPENING THROUGH SOUND WAVES (TARGETED ULTRASOUND)
- FIGURE 16 METHODS OF CROSSING THE BBB
- ENHANCING BIOLOGICAL TRANSPORT SYSTEM TECHNIQUES
- NANOPARTICLES AND LIPOSOMES
- NANOPARTICLES
- TABLE 8 DESIRABLE NANOPARTICLE QUALITIES TO ACT AS BBB TECHNOLOGY
- Challenges with Nanoparticles
- Liposomes
- CHAPTER FOUR: DRUGS FOR TREATING MENTAL DISORDERS: TECHNOLOGIES AND GLOBAL MARKETS (PHM074A)
- INTRODUCTION
- STUDY GOALS AND OBJECTIVES
- REASONS FOR DOING THIS STUDY
- SCOPE OF REPORT
- METHODOLOGY AND INFORMATION SOURCES
- INTENDED AUDIENCE
- ANALYST CREDENTIALS
- RELATED REPORTS
- SUMMARY
- TABLE 9 GLOBAL MENTAL HEALTH PHARMACEUTICAL INDUSTRY BY DRUG CATEGORY, THROUGH 2015 ($ BILLIONS)
- FIGURE 17 GLOBAL MENTAL HEALTH PHARMACEUTICAL INDUSTRY BY DRUG CATEGORY, 2009-2015 ($ BILLIONS)
- INTRODUCTION
- HISTORICAL OVERVIEW
- SCIENTIFIC BREAKTHROUGHS IN MENTAL HEALTH RESEARCH
- DRIVERS AND CHALLENGES OF THE MENTAL HEALTH PHARMACEUTICAL MARKET
- MENTAL HEALTH ORGANIZATIONS
- CITIZENS COMMISSION ON HUMAN RIGHTS (CCHR)
- NATIONAL ALLIANCE OF MENTAL ILLNESS (NAMI)
- MENTAL HEALTH AMERICA (MHA)
- NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH)
- GENERAL OVERVIEW OF THE MENTAL HEALTH PHARMACEUTICAL MARKET
- TABLE 10 GLOBAL MENTAL HEALTH PHARMACEUTICAL MARKET SHARES BY DRUG CATEGORY, 2010 (%)
- FIGURE 18 GLOBAL MENTAL HEALTH PHARMACEUTICAL MARKET SHARES BY DRUG CATEGORY, 2010 (%)
- DIAGNOSTICS FOR MENTAL ILLNESSES
- OVERVIEW
- TABLE 11 U.S. LIFETIME PREVALENCE OF MENTAL HEALTH DISORDERS BY TYPE OF ILLNESS, 2009 (%)
- GENETIC FACTORS OF MENTAL HEALTH DISORDERS AND BIOMARKER DEVELOPMENT
- TABLE 12 GENETIC FACTORS ASSOCIATED WITH MENTAL HEALTH DISORDERS AND CURRENT DIAGNOSTIC TESTS
- Bipolar Disorder
- TABLE 13 RISK OF DEVELOPING BIPOLAR DISORDER BASED ON FAMILIAL RELATIONSHIP (%)
- ANK3/CACNA1C Gene Candidates
- GRK3
- NEW DIAGNOSTIC TOOLS FOR BIPOLAR DISORDER BASED ON GENETIC FINDINGS
- Schizophrenia
- TABLE 14 U.S. STATISTICAL RISK OF DEVELOPING SCHIZOPHRENIA BASED ON FAMILIAL RELATIONSHIP (%)
- New Diagnostics for Schizophrenia
- CMYA 5
- Chromosomal Deletions
- Depression
- New Diagnostics for Depression
- BIOMARKER MARKET FOR CNS DISORDERS
- TABLE 15 GLOBAL MARKET FORECAST FOR BIOMARKERS FOR CNS DISORDERS AND DIAGNOSTICS TESTS, THROUGH 2015 ($ MILLIONS)
- Examples of Industry-Academia Collaborations as Drivers of Biomarker Development
- PSYCHOTHERAPY FOR THE TREATMENT OF MENTAL DISORDERS
- TABLE 16 U.S. PSYCHOTHERAPY TREATMENT STATISTICS, 2009
- CHAPTER FIVE: GENERIC DRUGS: THE GLOBAL MARKET (PHM009F)
- INTRODUCTION
- STUDY GOALS AND OBJECTIVES
- REASONS FOR DOING THE STUDY
- SCOPE OF REPORT
- MARKET ANALYSES AND FORECASTS
- METHODOLOGY
- INTENDED AUDIENCE
- INFORMATION SOURCES
- ANALYST CREDENTIALS
- RELATED REPORTS
- SUMMARY
- MARKET SIZE AND EVOLUTION
- TABLE 17 MAJOR GENERICS MARKETS, THROUGH 2016 ($ BILLIONS)
- FIGURE 19 MAJOR GENERICS MARKETS, THROUGH 2016 ($ BILLIONS)
- OVERVIEW
- TABLE 18 GLOBAL PHARMACEUTICAL AND GENERICS MARKETS, THROUGH 2016 ($ BILLIONS)
- RECENT HISTORY OF THE GENERICS SECTOR
- ROCHE-BOLAR
- GENERICS LOBBY
- ICH
- THE NEW GENERICS ERA
- THE PATENT CLIFF
- TABLE 19 FIRST PATENT EXPIRIES, 2012-2023
- TYPES OF GENERICS
- “SIMPLE” GENERICS
- Factors Influencing the Success or Failure of Generics
- Adequate Market Size
- Patent-Expired Therapies
- Older Products Still Used
- Long-Term Use
- Straightforward Production Technology
- Drugs Used in Primary Care
- SUPERGENERICS
- BIOSIMILARS
- TABLE 20 BIOLOGICS FACING THE LAUNCH OF BIOSIMILARS, 2001-2006
- Special Challenges
- Special Challenges (Continued)
- The Biosimilar Market
- Some Biosimilar Developments and Introductions
- EPO
- G-CSF
- Interferons
- HGH
- Monoclonal Antibodies
- Monoclonal Antibodies (Continued)
- CHAPTER SIX: VACCINE TECHNOLOGIES AND GLOBAL MARKETS (PHM014D)
- INTRODUCTION
- STUDY OBJECTIVES
- REASONS FOR DOING THIS STUDY
- INTENDED AUDIENCE
- SCOPE OF THE STUDY
- METHODOLOGY
- INFORMATION SOURCES
- ABOUT THE AUTHOR
- RELATED BCC RESEARCH REPORTS
- EXECUTIVE SUMMARY
- TABLE 21 GLOBAL REVENUE OF HUMAN AND ANIMAL VACCINES, THROUGH 2015 ($ MILLIONS)
- FIGURE 20 GLOBAL REVENUE OF HUMAN AND ANIMAL VACCINES, 2008-2015 ($ MILLIONS)
- INDUSTRY STRUCTURE
- WHO-PREQUALIFIED VACCINE MANUFACTURERS/SUPPLIERS
- TABLE 22 WORLD HEALTH ORGANIZATION (WHO)-PREQUALIFIED MANUFACTURERS/SUPPLIERS OF HUMAN VACCINES, 2010
- MANUFACTURERS/SUPPLIERS OF HUMAN VACCINES
- Attenuated (Live) Vaccines
- TABLE 23 LEADING MANUFACTURERS/SUPPLIERS OF ATTENUATED (LIVE) VACCINES
- Inactivated (Killed) Vaccines
- TABLE 24 LEADING MANUFACTURERS/SUPPLIERS OF INACTIVATED (KILLED) VACCINES
- CONJUGATE VACCINES
- TABLE 25 LEADING MANUFACTURERS/SUPPLIERS OF CONJUGATE VACCINES
- Recombinant/Recombinant DNA (rDNA) Vaccines
- TABLE 26 LEADING MANUFACTURERS/SUPPLIERS OF RECOMBINANT/ RECOMBINANT DNA (RDNA) VACCINES
- Subunit Vaccines
- TABLE 27 LEADING MANUFACTURERS/SUPPLIERS OF SUBUNIT VACCINES
- Toxoid Vaccines
- TABLE 28 LEADING MANUFACTURERS/SUPPLIERS OF TOXOID VACCINES
- Combination Vaccines
- TABLE 29 LEADING MANUFACTURERS/SUPPLIERS OF COMBINATION VACCINES
- MARKET SHARES OF INDUSTRY LEADERS OF HUMAN VACCINES
- Attenuated (Live) Vaccines
- TABLE 30 GLOBAL MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF ATTENUATED (LIVE) VACCINES, 2009 (%)
- FIGURE 21 GLOBAL MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF ATTENUATED (LIVE) VACCINES, 2009 (%)
- Inactivated (Killed) Vaccines
- TABLE 31 GLOBAL MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF INACTIVATED (KILLED) VACCINES, 2009 (%)
- FIGURE 22 GLOBAL MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF INACTIVATED (KILLED) VACCINES, 2009 (%)
- Conjugate Vaccines
- TABLE 32 GLOBAL MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF CONJUGATE VACCINES, 2009 (%)
- FIGURE 23 GLOBAL MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF CONJUGATE VACCINES, 2009 (%)
- Recombinant/Recombinant DNA (rDNA) Vaccines
- TABLE 33 GLOBAL MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF RECOMBINANT/RECOMBINANT DNA (RDNA) VACCINES, 2009 (%) .... 164
- FIGURE 24 GLOBAL MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF RECOMBINANT/RECOMBINANT DNA (RDNA) VACCINES, 2009 (%) .... 164
- Subunit Vaccines
- TABLE 34 GLOBAL MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF SUBUNIT VACCINES, 2009 (%) .... 165
- FIGURE 25 GLOBAL MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF SUBUNIT VACCINES, 2009 (%)
- Toxoid Vaccines
- TABLE 35 GLOBAL MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF TOXOID VACCINES, 2009 (%)
- FIGURE 26 GLOBAL MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF TOXOID VACCINES, 2009 (%)
- COMBINATION VACCINES
- TABLE 36 GLOBAL MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF COMBINATION VACCINES, 2009 (%)
- FIGURE 27 GLOBAL MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF COMBINATION VACCINES, 2009 (%)
- CHAPTER SEVEN: THE CLINICAL TRIALS BUSINESS (PHM027C)
- INTRODUCTION
- STUDY GOALS AND OBJECTIVES
- REASONS FOR DOING THE STUDY
- INTENDED AUDIENCE
- METHODOLOGY
- ANALYST CREDENTIALS
- SCOPE OF REPORT
- INFORMATION SOURCES
- RELATED BCC REPORTS
- SUMMARY
- TABLE 37 U.S. FORECAST OF SPONSORED CLINICAL TRIALS MARKET, THROUGH 2014
- FIGURE 28 U.S. FORECAST OF SPONSORED CLINICAL TRIALS MARKET, 2009-2014 ($ BILLIONS)
- OVERVIEW
- TYPES OF CLINICAL TRIALS
- CLINICAL TRIAL PHASES
- WHO SPONSORS CLINICAL TRIALS?
- TABLE 38 U.S. FORECAST OF SPONSORED CLINICAL TRIALS, THROUGH 2014
- FIGURE 29 U.S. SPONSORED CLINICAL TRIALS MARKET, 2009-2014 ($ BILLIONS)
- FIGURE 30 DRUG DEVELOPMENT TIME LINE
- TABLE 39 PHASES OF THE CLINICAL TRIAL
- PHASE I
- PHASE II
- PHASE III
- PHASE IV/POST-MARKETING TRIALS
- FACTORS AFFECTING STUDY SIZE
- PHYSICIAN AND PATIENT RECRUITMENT
- U.S. GOVERNMENT REGULATIONS
- PHARMACEUTICALS AND BIOLOGICS
- TABLE 40 U.S. LAWS AFFECTING DRUG APPROVAL TIMES
- Additional U.S. Laws Affecting Clinical Trials
- Health Insurance Portability and Accountability Act of 1996 (HIPAA)
- Best Pharmaceuticals for Children Act (BPCA), 2002
- TABLE 41 TOTAL APPROVED ACTIVE MOIETIES WITH NO MARKETING PROTECTION FOR WHICH FDA HAS ISSUED A WRITTEN REQUEST
- FOOD AND DRUG ADMINISTRATION (FDA)
- Background
- Center for Biologics Evaluation and Research (CBER)
- CBER and Bioterrorism
- Center for Drug Evaluation and Research (CDER)
- CDER and Bioterrorism
- Critical Path Initiative (CPI)
- MEDICAL DEVICES
- Center for Devices and Radiologic Health (CDRH)
- Articles Subject to Medical Device Amendments
- Classification of Devices (General Section 513)
- Class I—General Controls
- Class II—Special Controls
- Class III
- Expedited Review
- FIGURE 31 NEW DRUG DEVELOPMENT
- TABLE 42 CDER APPROVAL TIMES FOR PRIORITY AND STANDARD NDAS AND BLAS, CALENDAR YEARS, 1993-2008
- Expedited Development and Review
- TABLE 43 FIRST CYCLE APPROVAL RATE FOR OVERALL STUDY COHORT BY YEAR, 2002-2007
- Subpart E
- Accelerated Approval (Subpart H)
- Priority Review
- Fast Track
- TABLE 44 NUMBER AND TOTAL APPROVAL TIME (IN MONTHS) OF APPROVED NDAS AND BLAS BY FISCAL YEAR OF SUBMISSION AND BY REVIEW PROCEDURE
- Pediatrics
- U.S. LITIGATION AND CLINICAL TRIALS
- TABLE 45 INSURANCE COMPANIES OFFERING CLINICAL TRIAL LIABILITY INSURANCE
- INVESTIGATIONAL REVIEW BOARD (IRB)
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