Navigation Links
Evidera Announces Release of FDA Draft Guidance on Use of the "EXACT" to Measure Symptoms of COPD Exacerbations
Date:1/14/2014

to develop a PRO instrument for use in medical product development trials. The resulting instrument and a derivative measure, the EXACT-Respiratory Symptoms scale (E-RS), are the first to undergo qualification review by the FDA. These instruments are also under qualification review by the European Medicines Agency (EMA). Evidera maintains copyrights to the EXACT and E-RS in English and all translations (50 to date).

"After years of development and testing, with contributions from a diverse team of scholars, practitioners, industry experts, and patients, the release of this draft guidance represents a major milestone for the EXACT," said Nancy Kline Leidy, PhD, Senior Vice President, Scientific Affairs for Evidera and Principal Investigator and Director of EXACT-PRO Initiative.  "Furthermore, as the first qualification guidance from the FDA addressing a specific PRO measure, it could well constitute a significant advancement for PROs in drug development."

FDA qualification of drug development tools is designed to expedite the drug development process, in this case, research on the effects of new treatments on exacerbations of COPD. The EXACT draft guidance is the first for a PRO instrument, and follows on the heels of the FDA's release of the final Guidance for Industry and FDA Staff – Qualification Process for Drug Development Tools. The draft qualification guidance document for the EXACT was posted on the Federal Register January 10, with public comments due to the FDA within 90 days.  When finalized, the qualification guidance for the EXACT will represent the FDA's current thinking on the use of this PRO instrument in drug development. 

Chronic obstructive pulmonary disease (COPD), including emphysema and chronic bronchitis, is a progressive lung disease that causes breathle
'/>"/>

SOURCE Evidera
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Precision Optics Corporation Announces $1 Million Order for Microprecision™ Based Endoscopes
2. Young Innovations, Inc. Announces Record Sales and EPS for the Quarter Ended March 31, 2012
3. JDRF Announces Research Collaboration with Dexcom, Inc. to Develop "Smart Transmitter" Technology to Accelerate Artificial Pancreas Studies
4. Misonix Announces New Distribution Agreement For Panama
5. University of Maryland BioPark Announces MedImmunes Dr. Bahija Jallal as Newest Member of Board of Directors for UM Health Sciences Research Park
6. Novelos Therapeutics Announces Successful Completion of First Cohort In Lung Cancer Trial With I-124-CLR1404 (LIGHT) Cancer-Targeted PET Imaging Agent at UW Carbone Cancer Center
7. Boston Scientific Announces CE Mark and European Launch of Emerge™ PTCA Dilatation Catheter
8. Soligenix Announces Further Progress with ThermoVax™ for Long-Term Vaccine ThermoStability
9. Masimo Announces New Low-Profile Infant and Neonatal Pulse Oximetry Sensors
10. Anthera Announces the Completion of Patient Dosing in Phase 2b PEARL-SC Study
11. STAAR Surgical Announces First Quarter 2012 Results Release Date and Conference Call and Webcast
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/22/2014)... CORONA, Calif. , Sept. 22, 2014  AVT, ... in automated retailing systems and custom vending machines, announced ... Opticwash Pro Unit. This new, smaller sized unit is ... Professional (ECP) practices. According to industry statistics, ... Opticwash is the world,s first ...
(Date:9/22/2014)... 2014  Neuralstem, Inc. (NYSE MKT: CUR) announced that ... Emory University, presented long-term follow up data on the ... in the treatment of amyotrophic lateral sclerosis (ALS or ... at the Annual Symposium on ALS of the Foundation ... Friday, and was not open to the public, covered ...
(Date:9/22/2014)... N.J. , Sept. 22, 2014 /PRNewswire/-- CANTEL MEDICAL CORP. (NYSE: ... fourth quarter and fiscal 2014 ended July 31, 2014 on ... conference call to discuss the results at 11:00 AM ET. ... , Chairman; Andrew A. Krakauer , President and CEO; ... Craig A. Sheldon , Senior Vice President, CFO and ...
Breaking Medicine Technology:Opticwash Pro Enables Optical Retailers to Generate New Revenues and Customer Traffic through a Unique Eyeglass Cleaning System 2Neuralstem ALS Investigator Presents Long-Term Follow Up Phase I Data 2Neuralstem ALS Investigator Presents Long-Term Follow Up Phase I Data 3Neuralstem ALS Investigator Presents Long-Term Follow Up Phase I Data 4Cantel Medical Corp. To Hold Conference Call To Discuss Results For Its Fourth Quarter And Fiscal 2014 Ended July 31, 2014 2
(Date:9/22/2014)... HealthDay Reporter MONDAY, Sept. 22, 2014 ... intensive care units (NICU) set up private rooms for parents ... Researchers at one children,s hospital found that preemies gained ... their NICU switched from the traditional "open-bay" layout to private ... in the journal Pediatrics , add to evidence that ...
(Date:9/22/2014)... Alan Mozes HealthDay Reporter ... Many American parents are aware of online physician-rating sites, and ... for their children, according to a new national study. ... parents -- further suggest that negative online ratings may dissuade ... been recommended by a neighbor. Conversely, a positive online ...
(Date:9/22/2014)... whole eye transplant seems futuristic, if not impossible. ... Department of Defense, researchers at University of California, ... make implantation of an entire, functional eye a ... a holy grail for vision restoration," said Jeffrey ... co-recipient with colleagues at University of Pittsburg Medical ...
(Date:9/22/2014)... scientists have found that an anticonvulsant drug may help ... Although dozens of antibiotics target what bacteria do, their ... bacteria are created, and they found there is a ... important as there is growing concern worldwide about how ... The World Health Organization has declared that antibiotic resistance ...
(Date:9/22/2014)... PITTSBURGH, PA (PRWEB) September 22, 2014 ... caring for patients to the problem of side-sleeping. "My ... my side, so I designed a solution to this ... fall asleep comfortably than to have your arm 'fall ... sleep on his or her side more comfortably. It ...
Breaking Medicine News(10 mins):Health News:Newborn ICUs With Private Family Rooms Benefit Preemies: Study 2Health News:Newborn ICUs With Private Family Rooms Benefit Preemies: Study 3Health News:Many Parents Use Online Ratings to Pick a Pediatrician, Study Finds 2Health News:Many Parents Use Online Ratings to Pick a Pediatrician, Study Finds 3Health News:Looking ahead: Whole eye transplant under development 2
... body of basic animal research and studies of abused ... for the hypothesis that individuals with particular genotypes are ... with the abuse of alcohol and other substances. ... assume that these genotypes identify people who are predestined ...
... Board of Directors Audit Committee Members and Complies with ... BioPharma, Inc. (PDL) (Nasdaq: PDLI ) today ... J. Wilson as vice president of finance and principal ... team. She brings over twenty years of finance ...
... of Suntan Lotions, Reducing Risk of Deadly Skin Cancer ... & Prevention MonthNEW YORK, April 29 The ... people avoid overexposure to harmful ultraviolet radiation from the ... all across America reduce the risk of skin cancer ...
... 23-month-old child in Texas; CDC warns more deaths are ... 23-month-old child in Texas has become the first U.S. ... officials said Wednesday morning. , Dr. Richard Besser, acting ... Prevention, confirmed the death. No other details on the ...
... Dr. Gordon Norman presents overview of US healthcare ... Federation of Health Plans Meeting in Boston- Noted ... value for its healthcare investment- Emphasized greater coordination ... resolve today,s healthcare challenges MARIETTA, Ga., April 29 ...
... & Mentally IllNEW YORK, April 29 May marks ... it, philanthropic-minded New Yorkers will raise money for Weston ... and physically disabled. As federal and state funding ... the current economy, supporters will raise funds amidst live ...
Cached Medicine News:Health News:Genetic risk for anxiety does not have to be destiny 2Health News:PDL BioPharma Appoints Karen J. Wilson as Vice President, Finance and Principal Accounting Officer 2Health News:Easy-to-Use Wristband Tells You When to Apply Sunscreen - and When to Hit the Shade 2Health News:Easy-to-Use Wristband Tells You When to Apply Sunscreen - and When to Hit the Shade 3Health News:U.S. Reports First Swine Flu Death 2Health News:U.S. Reports First Swine Flu Death 3Health News:Alere's Dr. Gordon Norman Highlights Challenges and Promising Solutions to U.S. Healthcare System to International Health Insurance Executives 2Health News:Alere's Dr. Gordon Norman Highlights Challenges and Promising Solutions to U.S. Healthcare System to International Health Insurance Executives 3Health News:Weston United Celebrates Mental Health Month on May 19th 2
... Human Insulin-like growth factor binding protein-2 ... (further IGFBPs have been proposed) which specifically ... and IGF-II. The binding affinity of IGFBP-2 ... higher than for IGF-I [1], suggesting a ...
... Insulin-like growth factor binding protein-2 (IGFBP-2) is ... have been proposed) which specifically bind and ... The binding affinity of IGFBP-2 for IGF-II ... for IGF-I [1], suggesting a role in ...
... Androstenedione, produced in the adrenal gland and ... testosterone and estrone, both of which may ... relatively weak androgenic activity, estimated at ~(less ... [1]. However, serum androstenedione levels often exceed ...
... proteins that suppress the secretion of FSH ... consists of two distinct chains, or subunits ... consists of the alpha-subunit and betaA-subunit. Inhibin ... Only the dimeric forms of the molecule, ...
Medicine Products: