Navigation Links
Premier Research Announces Milestone Investigational New Drug Application
Date:4/7/2009

PHILADELPHIA, April 7 /PRNewswire/ -- Premier Research Group Limited, the international pharmaceutical services company, is pleased to announce that it has submitted an Investigational New Drug Application which represents the 50th IND under management. The milestone IND was submitted to the FDA's Division of Anesthesia, Analgesia and Rheumatology Products (DAARP), and is intended to support the clinical development of a novel formulation of a non-steroidal anti-inflammatory drug for the treatment of pain.

"This submission to DAARP expands our considerable experience in CDER Divisions and supports a development program for a new drug as a 505(b)(2) NDA, a strategy used by many small to mid-sized biopharmaceutical companies", noted James Ottinger, Vice President, Global Consulting and Compliance.

Premier Research acquired its U.S. regulatory affairs capabilities in 2006 in order to provide regulatory consulting to its U.S. and Internationally-based clients.

About Premier Research

Premier Research is a leading global solutions-driven CRO committed to therapeutic focus and operational expertise to deliver clinical trial services of the highest quality for biopharmaceutical and medical device companies. They are leaders in clinical research for analgesia, CNS, oncology, and infectious disease and have a wealth of experience in medical device and pediatric research.

Premier Research has 32 offices and operates in more than 30 countries across North America and Europe employing more 1,200 clinical professionals dedicated first and foremost to fulfilling each client's requirements in a timely, accurate, and cost-effective manner. This includes a strong international network of monitors and project management professionals combined with regulatory, data management, statistical, scientific and medical experts, and staff at our well-established network of dedicated clinical sites.

www.premier-research.com


'/>"/>
SOURCE Premier Research Group Limited
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Premier Research Expands its Medical Device Operations to the United States
2. Premier Research Announces Milestone New Drug Application
3. Premier Research Honored as Clinical Research Team of the Year at 2008 GCPj Awards
4. Groundbreaking American Journal of Play from Strong National Museum of Play(R) Premiers July 2008
5. CV Therapeutics Announces Archives of Internal Medicine Publication of Study Showing 20 Percent of Heart Attack Patients in Premier Registry Experienced Angina at One Year
6. Premier Micronutrient Launches Supplement for Hearing Health
7. Interleukin Genetics Presents Research Linking Vertebral Fractures to Gene Variations in Asian Women With Osteoporosis
8. BARC Central Laboratory Joins Alzheimers Association Research Roundtable
9. Lilly Announces Inconclusive Phase II Study Results for mGlu2/3 at the International Congress on Schizophrenia Research
10. First Year Results of the AXA Research Fund: Over Euro 13 Million Allocated for Research in 2008
11. U.S. Naval Medical Research Center Resubmits IND Application for Proposed RESUS Clinical Trial in Trauma Patients in the Out-of-Hospital Setting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/28/2017)... , Sept. 28, 2017 Cohen Veterans Bioscience ... the use of wearable and home sensors for real-time ... Early Signal Foundation, a nonprofit organization focused on disruptive ... provide an affordable analytical system to record and integrate ... ...
(Date:9/25/2017)... , Sept. 25, 2017  EpiVax, Inc., a ... design, and immune-engineering today announced the launch of ... development of personalized therapeutic cancer vaccines. EpiVax has ... exclusive access to enabling technologies to the new ... will lead EpiVax Oncology as Chief Executive Officer. ...
(Date:9/19/2017)... Mich. , Sept. 19, 2017 HistoSonics, Inc., a venture-backed medical device company ... destruction of targeted tissues, announced three leadership team developments today:   ... PhD ... ... Veteran medical device executive Josh ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... ... Agile Software Development, has been awarded a contract by the Center for Medicare ... (BPA) aims to accelerate the enterprise use of Agile methodologies in a consistent ...
(Date:10/12/2017)... ... October 12, 2017 , ... CitiDent and San ... using cutting-edge Oventus O2Vent technology. As many as 18 million Americans are ... cessation in breathing. Oral appliances can offer significant relief to about 75 percent ...
(Date:10/12/2017)... ... October 12, 2017 , ... The American College of Medical Informatics ... PhD, FACMI, during the Opening Session of AMIA’s Annual Symposium in Washington, D.C. AMIA’s ... of Morris F. Collen, a pioneer in the field of medical informatics, this prestigious ...
(Date:10/12/2017)... ... October 12, 2017 , ... HMP , a leader in ... 2017 Folio Magazine Eddie Digital Award for ‘Best B-to-B Healthcare Website.’ Winners were announced ... 2017. , The annual award competition recognizes editorial and design excellence across a range ...
(Date:10/12/2017)... ... 2017 , ... Health Literacy Innovations (HLI), creator of the ... the Cancer Patient Education Network (CPEN), an independent professional organization that shares best ... alliance. , As CPEN’s strategic partner, HLI will help support CPEN members ...
Breaking Medicine News(10 mins):