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Evidera Announces Release of FDA Draft Guidance on Use of the "EXACT" to Measure Symptoms of COPD Exacerbations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with contributions from a diverse team of scholars, practitioners, industry experts, and patients, the release of this draft guidance represents a major milestone for the EXACT," said Nancy Kline Leidy, PhD, Senior Vice President, Scientific Affairs for Evidera and Principal Investigator and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 The EXACT draft guidance is the first for a PRO instrument, and follows on the heels of the FDA's release of the final Guidance for Industry and FDA Staff – Qualification Process for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:10/22/2014)...  Charlene Vernak, RPh, of Vernak Farms Pharmacy in ... awarded the George Roentsch Scholarship by the Professional Compounding ... Houston during PCCA,s International Seminar, ... to an independent pharmacist and PCCA member who embodies ... , a well-known pharmacist in the compounding community. ...
(Date:10/22/2014)... SAN FRANCISCO , Oct. 22, 2014 ... fitness and health trackers for themselves and their kids, ... Mom 2014 Report: Health & Fitness Go Mobile for ... Mom® Insights Series. BabyCenter, the number 1 pregnancy and ... which found that 55 percent of moms surveyed say ...
(Date:10/22/2014)... AVACEN Medical announced today that its AVACEN ... clearance by the U.S. Food and Drug Administration. This ... the Internet for: the temporary relief of joint ... and sprains . Logo - http://photos.prnewswire.com/prnh/20141021/153513 ... is a sophisticated medical device incorporating over 3,000 firmware ...
Breaking Medicine Technology:PCCA Awards Charlene Vernak, RPh, the George Roentsch Scholarship 2BabyCenter Finds Mom Ready to Live the "Measured Life" in its U.S. Mobile Mom 2014 Report: Health & Fitness Go Mobile for Moms 2BabyCenter Finds Mom Ready to Live the "Measured Life" in its U.S. Mobile Mom 2014 Report: Health & Fitness Go Mobile for Moms 3BabyCenter Finds Mom Ready to Live the "Measured Life" in its U.S. Mobile Mom 2014 Report: Health & Fitness Go Mobile for Moms 4AVACEN Medical Announces FDA Clearance of First Medical Device with Internal Game Mode 2
... ConvaTec Healthcare, a world-leading developer, manufacturer and marketer of ... announced that, following a review of current conditions in ... its senior secured term loans originally entered into on ... a leading developer and marketer of innovative medical technologies. ...
... therapy for chronic pain who may not be following ... Ameritox Ltd. announced recently. The study was published in ... "Considering all of the discussion right now ... highlights an opportunity to better manage a costly and ...
Cached Medicine Technology:ConvaTec Healthcare Postpones Plans To Refinance Secured Term Loans 2ConvaTec Healthcare Postpones Plans To Refinance Secured Term Loans 3Study of Patients on Chronic Opioid Therapy finds Likely Non-adherent Patients Have Increased Healthcare Costs, More Hospital Days 2Study of Patients on Chronic Opioid Therapy finds Likely Non-adherent Patients Have Increased Healthcare Costs, More Hospital Days 3
(Date:10/22/2014)... 2014 Medical Solutions , ... happy to announce that our co-founder and CFO, ... Analysts’ Staffing 100 for 2014. Anderson was also ... influential people in the staffing industry,” in 2013.     ... 13th-largest healthcare staffing company in the U.S., was ...
(Date:10/22/2014)... Amy Norton HealthDay Reporter ... riveted on the three Ebola cases in Dallas. But, mental ... threat to Americans. President Barack Obama on Friday appointed ... virus, which has infected two Dallas nurses who cared for ... Texas Health Presbyterian Hospital. But the U.S. cases are ...
(Date:10/22/2014)... 22, 2014 The Louis ... is dedicated to distribute health information technology innovation ... worldwide announced the development of six key guiding ... when receiving healthcare. These are an expansion of ... “providing care that is respectful of and responsive ...
(Date:10/22/2014)... During the Western United States’ worst ... dangerously low, Southern Oregon’s water is proving resistant to ... lowest mountain snow pack on record in 2014, remain ... autumn.* That was the observation of journalist-hikers Art Bernstein ... Southern Oregon,” during an interview with water advocate Sharon ...
(Date:10/22/2014)... Losing Weight Your Body’s Way , In a world ... face, it certainly can be difficult to choose the right ... favor by doing it the healthy way? Set aside the ... your body, exercise regularly, and choose foods with the most ... you need to exercise more and eat less. Despite the ...
Breaking Medicine News(10 mins):Health News:Medical Solutions Co-Founder/CFO Scott Anderson Named to Staffing Industry Analysts’ 2014 Staffing 100 2Health News:Medical Solutions Co-Founder/CFO Scott Anderson Named to Staffing Industry Analysts’ 2014 Staffing 100 3Health News:Ebola Anxiety: A Bigger Threat Now Than the Virus Itself 2Health News:Ebola Anxiety: A Bigger Threat Now Than the Virus Itself 3Health News:The Sullivan Institute for Healthcare Innovation Announces Release of Guiding Principles for Patient Experience-Centered Care 2Health News:Southern Oregon Is West’s Most Drought Proof Fresh Water Region Say Hiking Guide Authors 2Health News:Southern Oregon Is West’s Most Drought Proof Fresh Water Region Say Hiking Guide Authors 3Health News:Southern Oregon Is West’s Most Drought Proof Fresh Water Region Say Hiking Guide Authors 4Health News:ReductionGuruMD Presents Ways to Improve Your Weight Loss Results 2
... Iraq may not show sign of problems right away, study ... 40 percent of the U.S. soldiers from the Iraq and ... disorders or psychosocial behavioral problems, a new study shows. , ... found that most mental health diagnoses were not made in ...
... , NEW YORK and LOS ANGELES, July 16 ... The Cleaner , with Benjamin Bratt starring as an ,extreme ... producer Warren Boyd. What,s encouraging about The Cleaner is ... of addictive behavior. With more than 23 million Americans misusing drugs ...
... one of many dangers for children in unattended vehicles, experts ... time of year, but especially in warm weather, don,t even ... New research from the U.S. National Highway Traffic Safety Administration ... children is hyperthermia, better known as heat stroke. , ...
... , OAKLAND, Calif., July 16 Arcadian Health announced ... to present at the BMO Capital Markets sponsored 9th Annual Focus ... at the Millennium Broadway Hotel. Arcadian is a leading provider of ... hospitals, health plans and other provider groups. , ...
... , , Archer: "We,re Determined to Make ... he Standard for Reform " , ... health care project director Diane Archer today praised the House for introducing ... that America,s Affordable Health Choices Act is designed to control costs and deliver quality ...
... Two common supplements lower body fat, build muscle in obese ... (HealthDay News) -- For certain people, dietary oil supplements could ... , Obese older women with type 2 diabetes who ... their diet either decreased their body mass index or boosted ...
Cached Medicine News:Health News:Many Veterans Need Mental Health Care 2Health News:Many Veterans Need Mental Health Care 3Health News:Many Veterans Need Mental Health Care 4Health News:Coming Clean About The Cleaner - Phoenix House's Chief Clinical Officer David Deitch on Intervention, and the Recovery Process That Follows 2Health News:Coming Clean About The Cleaner - Phoenix House's Chief Clinical Officer David Deitch on Intervention, and the Recovery Process That Follows 3Health News:Cars Are No Place for Kids to Be Alone 2Health News:Arcadian Chairman and Chief Executive Officer, Robert Fahlman, to Present at Focus on Healthcare Conference in New York City 2Health News:Dietary Oils May Help Some Fight Fat 2Health News:Dietary Oils May Help Some Fight Fat 3
0.5 mm, 1 x 2 teeth set at 45 degrees. Serrated handle with polished finish....
Serrated handle with 7 mm tying platform and polished finish. Teeth: 0.25 mm, 2 x 2 set at 45 degrees....
1 x 2 teeth and 5.5 mm tying platform. Round knurled handle with polished finish. Teeth: 0.3 mm....
6 mm tying platform. Round knurled handle with polished finish. Teeth: 0.3 mm, 1 x 2. Orientation: Left hand....
Medicine Products: