Navigation Links
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

TRE
'/>"/>

SOURCE Reportlinker
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9 10 11 12 13

Related medicine technology :

1. Reportlinker Adds Pharmaceutical Key Trends 2010
2. Reportlinker Adds Antiemetics: Technologies and Global Markets
3. Reportlinker Adds Anti-Counterfeiting Packaging Technologies in the Global Pharmaceutical and Food Industries
4. Reportlinker Adds European Markets for Dental Bone Graft Substitutes, Dental Membranes and Tissue Engineering 2011
5. Reportlinker Adds U.S. Market for Patient Monitoring Devices 2011
6. Reportlinker Adds European Markets for Video, High-Tech and Integrated OT Equipment 2011
7. Reportlinker Adds Corporate Strategies in Consumer Health 2010
8. Reportlinker Adds Allergic Conjunctivitis - Pipeline Assessment and Market Forecasts to 2017
9. Reportlinker Adds Chinese Markets for Drug Delivery System
10. Reportlinker Adds Prostate Cancer - Italy Drug Forecasts and Treatment Analysis to 2020
11. Reportlinker Adds Asia-Pacific Endoscopy Devices Market Outlook to 2016
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/30/2015)... August 30, 2015 La ... l cuidado al paciente ...   Royal Philips  (NYSE: PHG, ... IntelliSpace Cardiovascular , un sistema web de gestión ... acceder, analizar y compartir imágenes cardiovasculares e información en ...
(Date:8/29/2015)... 29, 2015 La sofisticada ... los sistemas de imagen por Ultrasonidos   ofrece resultados ... examen rápidos y un flujo de trabajo   optimizado, ... el proceso de detección de Cardiopatías   ... hoy el lanzamiento europeo de HeartModel A.I ...
(Date:8/28/2015)... Fla. , Aug. 28, 2015  With the ... reaching deadlier heights, Jacksonville -based ... Philip Hemphill is helping to explain why fentanyl ... is approximately 40 to 50 times more potent than ... recreational users as heroin, the risk of death skyrockets. ...
Breaking Medicine Technology:Philips presenta IntelliSpace Cardiovascular en el Congreso ESC 2015 2Philips presenta IntelliSpace Cardiovascular en el Congreso ESC 2015 3Philips presenta HeartModel A.I en el Congreso ESC 2015 2Philips presenta HeartModel A.I en el Congreso ESC 2015 3Philips presenta HeartModel A.I en el Congreso ESC 2015 4Philips presenta HeartModel A.I en el Congreso ESC 2015 5Lakeview Health's Dr. Philip Hemphill Explains Why Heroin Addicts Are Now Dying of Fentanyl Overdoses 2
(Date:8/30/2015)... ... August 30, 2015 , ... Scientists in France say asbestos exposure may put ... cancers. Surviving Mesothelioma has just posted an article on the new research. Click ... the cancer incidence among 2,024 French asbestos plant workers from 1978 to 2009. In ...
(Date:8/30/2015)... ... August 30, 2015 , ... InHealth Media ... the new Global Communications Director for InHealth Media. Mr. Spector comes with ... last 16 years doing on-air television, producing shows, on air-radio and media relations. ...
(Date:8/30/2015)... ... ... Natural Rest contains a unique mixture of vitamins and herbs that are ... to improve mood disorders and anxiety. Like all other Creative Medical Health products, Natural ... regenerative medicine conducted by Dr. Amit Patel of the University of Utah, one of ...
(Date:8/30/2015)... ... 2015 , ... Certified Nutrition Businessman Reid Eckert agrees to extend his business ... a global sales and communications firm that offers U.S. brands a proven path to ... with Mr. Reid Eckert, as his interpretation of the nutritional needs of the human ...
(Date:8/30/2015)... Fl (PRWEB) , ... August 30, 2015 , ... ... Executive Vice President Jeff Fernandez will lead the expansion of global cosmeceutical and ... and skin care experience having spent the last 25 years working in operations, ...
Breaking Medicine News(10 mins):Health News:Researchers Say Mesothelioma Not the Only Cancer Linked with Asbestos Exposure, According to Surviving Mesothelioma 2Health News:InHealth Media Appoints New Global Communications Director 2Health News:Creative Medical Health’s Natural Rest® Now Available on ReCreative Medical Health’s Natural Rest® Now Available on RevNutrition.com 2Health News:Nutrition Guru Continues Relationship With Renowned Health and Wellness Company 2Health News:NPI Executive Vice President Leads Cosmeceutical Expansion 2
... -- Researchers in the Memory Disorders Program at Georgetown University ... therapy trial the first study of its kind for ... The phase II study examines the safety ... and is injected during surgery into a part of the ...
... , WASHINGTON, Sept. 22 As ... American Red Cross for shelter as officials estimate the number of ... (Logo: http://www.newscom.com/cgi-bin/prnh/20090108/RedCrossLOGO ) , , ... shelters in Georgia, North Carolina, Alabama and Tennessee. Georgia has ...
... Finding explains why obese children have higher relapse rates, ... Leukemia cells can hide in fat tissue to evade ... are more likely to develop chemotherapy resistance and have ... found that obese children with leukemia are 50 percent ...
... , WASHINGTON, Sept. 22 The ... by tens of millions -- at zero cost to taxpayers -- ... an analysis just released by The National Center for Public Policy ... Representatives approved the American Clean Energy and Security Act, commonly referred ...
... PITTSBURGH, Sept. 22 Market leader TeleTracking Technologies, Inc. ... deliver a truly automatic, enterprise-wide patient flow system to the ... the pioneer of patient flow automation," said TeleTracking CEO Anthony ... time-tested, proven approach to manage real-time patient flow actions which ...
... PLAINES, Ill., Sept. 22 The Emergency Nurses Association (ENA) today ... be held in Baltimore, Maryland on October 7-10, 2009. , ... GE Healthcare, and Vidacare; and the Annual Conference Supporters are Catholic ... are so pleased that these companies have chosen to support emergency ...
Cached Medicine News:Health News:Historic gene therapy trial to treat Alzheimer's disease underway at Georgetown 2Health News:Red Cross Sheltering Those Hit by Floods in Southeast 2Health News:Leukemia Cells May Hide in Fat Tissue 2Health News:Cap and Trade Legislation Would Increase Uninsured by Millions 2Health News:TeleTracking Technologies Adds RTLS for Fully Automatic Patient Flow Automation 2Health News:Emergency Nurses Association Announces Corporate Supporters for 2009 Annual Conference 2
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
Medicine Products: