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Number of novel drugs approved annually by CDER 2008-2018
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Number of novel drugs approved annually by CDER 2008-2018
Total number of novel drugs approved by CDER from 2008 to 2018
by Matej Mikulic,
last edited
Jan 28, 2019
This statistic depicts the number of novel drugs approved by the Center for Drug Evaluation and Research (CDER) from 2008 to 2018. According to the data, in 2008, 24 novel drugs were approved by CDER, compared to 59 novel drugs in 2018.
Total number of novel drugs approved by CDER from 2008 to 2018
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by Matej Mikulic,
last edited
Jan 28, 2019
This statistic depicts the number of novel drugs approved by the Center for Drug Evaluation and Research (CDER) from 2008 to 2018. According to the data, in 2008, 24 novel drugs were approved by CDER, compared to 59 novel drugs in 2018.
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- As a Premium user you get access to the detailed source references and background information about this statistic.
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- Release date
- January 2019
- Region
- United States
- Survey time period
- 2008 to 2018
- Supplementary notes
- CDER (Center for Drug Evaluation and Research) is a regulatory agency and part of the U.S. Food and Drug Administration.
- Open this statistic in...
Source
- Show sources information
- As a Premium user you get access to the detailed source references and background information about this statistic.
- Show publisher information
- Release date
- January 2019
More information
- Region
- United States
- Survey time period
- 2008 to 2018
- Supplementary notes
- CDER (Center for Drug Evaluation and Research) is a regulatory agency and part of the U.S. Food and Drug Administration.
- Open this statistic in...
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Statistics on "Clinical trials"
- R&D overview
The most important statistics
- Total global spending on pharmaceutical research and development from 2010 to 2024 (in billion U.S. dollars)Total global pharmaceutical R&D spending 2010-2024
- Percentage of spending on research and development of total revenue from 2013 to 2017, by industrial sector*Industry sectors - expenditure on research and development 2013-2017
- Selected top pharmaceutical R&D projects based on net present value (NPV) as of May 2019 (in million U.S. dollars)Top pharmaceutical R&D projects based on net present value May 2019
- Research and development expenditure of total U.S. pharmaceutical industry from 1995 to 2018 (in billion U.S. dollars)*Research and development expenditure: U.S. pharmaceutical industry 1995-2018
- Pharmaceutical research and development spending in selected European countries in 2017 (in million euros)Research and development in European pharmaceutical industry by country 2017
- Total clinical research funding by the National Institutes for Health (NIH) from FY 2013 to FY 2019 (in million U.S. dollars)Total clinical research funding by National Institutes for Health 2013-2019
- Top R&D companies
The most important statistics
- Global top 10 pharmaceutical companies based on projected R&D spending in 2024 (in billion U.S. dollars)Global top pharmaceutical companies based on R&D spending 2024
- World's top 50 pharmaceutical and biotechnology companies based on R&D intensity in 2017/2018*Top 50 global pharmaceutical and biotech companies by R&D intensity in 2017/2018
- World's top 50 pharmaceutical and biotechnology companies based on R&D spending growth in 2017/2018Top pharmaceutical companies in R&D spending growth 2017-2018
- Number of patients who took part in clinical trials for pharmaceutical company Roche from 2009 to 2017*Roche: participation of patients in clinical trials 2009-2017
- Top global contract research organizations (CROs) based on 2017 revenue (in million U.S. dollars)Leading global contract research organizations based on revenue 2017
- Clinical studies
The most important statistics
- Complexity of clinical trials compared in 2001-2005 and 2011-2015Comparison between the complexity of clinical trials 2001-2015
- Increase in clinical trials' complexity between 2001-2005 and 2011-2015Increase in clinical trials' complexity 2001-2015
- Number of registered clinical studies worldwide by location as of August 2018Number of registered clinical studies by location worldwide 2018
- Percentage of registered clinical studies worldwide by location as of August 2018Percent of registered clinical studies worldwide by location 2018
- Percentage of registered recruiting clinical studies worldwide by location as of August 2018Share of recruiting clinical studies worldwide by location 2018
- Total number of registered clinical studies worldwide since 2000 (as of August 2018)*Total number of registered clinical studies worldwide since 2000
- Total number of registered clinical studies with posted results worldwide since 2009 (as of August 2018)*Total number of registered clinical studies with posted results worldwide 2009-2018
- Participation
The most important statistics
- Percentage of population enrolled in clinical trials in selected countries worldwide as of 2016Clinical trial enrollment by select country and region 2016
- Top 20 countries by number of clinical trial participants in 2015-2016Top clinical trial participant countries 2015-2016, by number
- Top 20 clinical trial participant countries worldwide in 2015-2016, by share of participants (in percentage)Top clinical trial participant countries worldwide 2015-16, by share
- Number of clinical trial participants in the U.S. and rest of the world in 2016, by therapeutic areaClinical trial participants U.S. vs. rest of world by therapy area 2016
- Gender share of clinical trial participants worldwide in 2015-2016, by geographic locationClinical trial participants gender share worldwide 2015-16, by geographic location
- Ethnicity share of clinical trial participants worldwide in 2015-2016, by geographic location (in percentage)Clinical trial participants ethnicity share worldwide 2015-16, by geographic location
- Costs and market
The most important statistics
- Cost of developing a drug in the U.S. from the 1970s until today (in million U.S. dollars)*Pharmaceuticals: cost of drug development in the U.S. since 1975
- Total R&D costs for selected cancer drugs on the market as of 2017 (in million U.S. dollars)Total R&D costs of select cancer drugs 2017
- Market share of clinical trials worldwide by segment as of 2016Market share of clinical trials worldwide by segment
- Clinical contract research organization (CRO) market worldwide from 2011 to 2020 (in billion U.S. dollars)Clinical CRO market size worldwide 2011-2020
- Size of the U.S. market for healthcare contract research outsourcing (CRO) from 2016 to 2022, by type (in million U.S. dollars)Size of U.S. healthcare CRO market 2016-2022 by type
- Size of the total U.S. clinical trial supplies market from 2016 to 2025 (in million U.S. dollars)Size of total U.S. clinical trial supplies market 2016-2025
- Success rates
The most important statistics
- Probability of success for drugs in the U.S. in different development phases between 2006 and 2015U.S. drug development phase success rates 2006-2015
- Probability of Phase II success for new drugs in select disease areas in the U.S. between 2006 and 2015U.S. drug development Phase II success rates 2006-2015, by disease area
- The probability of Phase III success for new drugs in select disease areas in the U.S. between 2006 and 2015U.S. drug development Phase III success rates from 2006 to 2015, by disease area
- Probability of success for oncology vs non-oncology drugs in the U.S. in the different development phases from 2006 to 2015U.S. development Phase success rates for oncology and non oncology drugs 2006-2015
- Probability of success for new drugs in the U.S. by development phase between 2006 and 2015, by drug classification U.S. drug development Phase success rates, by drug classification 2006-2015
- Probability of success for new drugs in the U.S. with and without selection biomarkers by development phase between 2006 and 2015U.S. development phase success rates for drugs with and without biomarkers 2006-2015
- Approvals, launches, setbacks
The most important statistics
- Number of new chemical or biological entities developed between 1992 and 2018, by region of originPharmaceutical industry - number of new substances 1992-2018
- Total number of novel drugs approved by CDER from 2008 to 2018Number of novel drugs approved annually by CDER 2008-2018
- Percentage of drugs approved by the U.S. Center for Drug Evaluation and Research (CDER) in 2018 that met select key measurementsKey measurements of U.S. CDER drug approvals in 2018
- Number of first premarket approvals (PMA/HDE) granted by the FDA for medtech products from 2005 to 2018FDA first premarket approvals for medtech products granted 2005-2018
- Top biotech and pharma product launches in 2018 and revenue forecast for 2022 (in million U.S. dollars)Projection of top 2018 pharma and biotech launches by revenue 2022
- Number of unsuccessful Alzheimer’s drugs in development in the U.S. from 1998 to 2017Number of unsuccessful Alzheimer’s drugs in development in the U.S. 1998-2017
- Unsuccessful attempts and new drugs for select cancer types between 1998 and 2014Unsuccessful attempts and new drugs for cancer types 1998-2014
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Statistics
- U.S. NDA/BLA filing approval for new drugs in select disease areas 2006-2015
- NDA/BLA filing to FDA approval times for new drugs in select disease areas 2006-2015
- Number of medicines in development for heart disease and stroke by type 2018
- U.S. pain medication clinical pipeline in 2017, by phase and indication
- FDA approved orphan drugs 1983-2018, by approval sequence
- Italy: number of biotech projects along the drug pipeline 2016-2017, by area
- Number of NAS approved by Health Canada 2011-2016
- Count of first-time medtech approvals granted by FDA 2006-2017
- New active substance approvals in OECD countries 2017, by country
- Annual cost of MS drugs by select countries 2013-2014
- New active substances among brand drugs sales Canada 2017, by launch year
- Annual cost of MS drugs in the United States from approval date to 2013
- Oncology or orphan drugs that were new active substances globally 2009-2017
- Average FDA approved orphan drug sales U.S. 5 years after launch 2014
- Revenue since approval for select cancer drugs 2017
- Availability of new medicines in Europe in 2018, by country
- Share of sales attributable to new active substances launched 2009-2016 by country
- Heparin global market size in 2017 and 2023
- Health and social care employees in Czechia 2000-2017
- Italy: average price of drugs provided by the NHS 2010-2017
Statistics on "Clinical trials"
- Total global spending on pharmaceutical research and development from 2010 to 2024 (in billion U.S. dollars)
- Percentage of spending on research and development of total revenue from 2013 to 2017, by industrial sector*
- Selected top pharmaceutical R&D projects based on net present value (NPV) as of May 2019 (in million U.S. dollars)
- Research and development expenditure of total U.S. pharmaceutical industry from 1995 to 2018 (in billion U.S. dollars)*
- Pharmaceutical research and development spending in selected European countries in 2017 (in million euros)
- Total clinical research funding by the National Institutes for Health (NIH) from FY 2013 to FY 2019 (in million U.S. dollars)
- Global top 10 pharmaceutical companies based on projected R&D spending in 2024 (in billion U.S. dollars)
- World's top 50 pharmaceutical and biotechnology companies based on R&D intensity in 2017/2018*
- World's top 50 pharmaceutical and biotechnology companies based on R&D spending growth in 2017/2018
- Number of patients who took part in clinical trials for pharmaceutical company Roche from 2009 to 2017*
- Top global contract research organizations (CROs) based on 2017 revenue (in million U.S. dollars)
- Complexity of clinical trials compared in 2001-2005 and 2011-2015
- Increase in clinical trials' complexity between 2001-2005 and 2011-2015
- Number of registered clinical studies worldwide by location as of August 2018
- Percentage of registered clinical studies worldwide by location as of August 2018
- Percentage of registered recruiting clinical studies worldwide by location as of August 2018
- Total number of registered clinical studies worldwide since 2000 (as of August 2018)*
- Total number of registered clinical studies with posted results worldwide since 2009 (as of August 2018)*
- Percentage of population enrolled in clinical trials in selected countries worldwide as of 2016
- Top 20 countries by number of clinical trial participants in 2015-2016
- Top 20 clinical trial participant countries worldwide in 2015-2016, by share of participants (in percentage)
- Number of clinical trial participants in the U.S. and rest of the world in 2016, by therapeutic area
- Gender share of clinical trial participants worldwide in 2015-2016, by geographic location
- Ethnicity share of clinical trial participants worldwide in 2015-2016, by geographic location (in percentage)
- Cost of developing a drug in the U.S. from the 1970s until today (in million U.S. dollars)*
- Total R&D costs for selected cancer drugs on the market as of 2017 (in million U.S. dollars)
- Market share of clinical trials worldwide by segment as of 2016
- Clinical contract research organization (CRO) market worldwide from 2011 to 2020 (in billion U.S. dollars)
- Size of the U.S. market for healthcare contract research outsourcing (CRO) from 2016 to 2022, by type (in million U.S. dollars)
- Size of the total U.S. clinical trial supplies market from 2016 to 2025 (in million U.S. dollars)
- Probability of success for drugs in the U.S. in different development phases between 2006 and 2015
- Probability of Phase II success for new drugs in select disease areas in the U.S. between 2006 and 2015
- The probability of Phase III success for new drugs in select disease areas in the U.S. between 2006 and 2015
- Probability of success for oncology vs non-oncology drugs in the U.S. in the different development phases from 2006 to 2015
- Probability of success for new drugs in the U.S. by development phase between 2006 and 2015, by drug classification
- Probability of success for new drugs in the U.S. with and without selection biomarkers by development phase between 2006 and 2015
- Number of new chemical or biological entities developed between 1992 and 2018, by region of origin
- Total number of novel drugs approved by CDER from 2008 to 2018
- Percentage of drugs approved by the U.S. Center for Drug Evaluation and Research (CDER) in 2018 that met select key measurements
- Number of first premarket approvals (PMA/HDE) granted by the FDA for medtech products from 2005 to 2018
- Top biotech and pharma product launches in 2018 and revenue forecast for 2022 (in million U.S. dollars)
- Number of unsuccessful Alzheimer’s drugs in development in the U.S. from 1998 to 2017
- Unsuccessful attempts and new drugs for select cancer types between 1998 and 2014
- Percent approval for NDA/BLA filings for new drugs in select disease areas in the U.S. between 2006 and 2015
- Time from NDA/BLA filings for new drugs to FDA approval in select disease areas in the U.S. between 2006 and 2015
- Number of medicines in development for heart diseases and stroke by type as of 2018
- Clinical pipeline for pain indications in the U.S. as of 2017, by phase and indication
- Number of FDA-approved orphan drugs between 1983 and 2018, by approval sequence
- Number of biotech projects along the drug pipeline in Italy between 2016 and 2017, by therapeutic area
- Number of new active substances (NASs) approved by Health Canada from 2011 to 2016*
- Number of medtech first-time approvals (PMA/HDE/PDP) granted by the FDA per year from 2006 to 2017*
- Number of new active substances approved with available sales in OECD countries as of Q4 2017, by country
- Multiple sclerosis drug annual cost in selected countries in 2013/2014 (in U.S. dollars)
- Percentage of name-brand drugs sales attributable to new active substances (NAS) in Canada as of 2017, by launch year
- Multiple sclerosis drug annual costs in the U.S. at approval date and in 2013 (in U.S. dollars)
- Share of orphan or oncology drugs launched globally that were new active substances (NAS) from 2009 to 2017
- Average orphan and non-orphan drug sales in the United States 5 years after launch in 2014*
- Total revenue since approval for select cancer drugs on the market as of 2017 (in million U.S. dollars)
- Number of medicines approved by the EMA available* to patients in Europe as of 2018, by country
- Percentage of sales attributable to new active substances launched in 2009-2016 in OECD countries as of Q4 2017
- Heparin global market in 2017 and a forecast for 2023 (in billion U.S. dollars)
- Number of employees in the health and social care industry in Czechia from 2000 to 2017 (in 1,000)
- Average price of drugs provided by the NHS in Italy from 2010 to 2017 (in euros)
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