Navigation Links
FDA, International Counterparts Report Progress on Drug Inspection Collaboration
Date:8/2/2011

SILVER SPRING, Md., Aug. 2, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration, together with its European and Australian counterparts, today released two reports detailing the results of pilot programs focused on increasing international regulatory collaboration among the agencies so that drug quality and safety can be enhanced globally.  

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

The report on the Good Clinical Practice (GCP) initiative details the success of information-sharing and collaboration on inspections relating to clinical trials. Under the GCP pilot program, the FDA and the European Medicines Agency (EMA) exchanged more than 250 documents relating to 54 different drug products and, in conjunction with the GCP inspectors of the EU member states, organized 13 collaborative inspections of clinical trials. This lays the foundation for a more efficient use of limited resources, improved inspectional coverage, and better understanding of each agency's inspection procedures. It demonstrates how the agencies can work together to improve human subject protection and better ensure the integrity of data submitted as the basis for drug approvals.

The report on the Active Pharmaceutical Ingredients initiative details the success of information-sharing among the FDA, Australia's Therapeutic Goods Administration and for Europe, the EMA, France, Germany, Ireland, Italy, the United Kingdom and European Directorate for the Quality of Medicines & Healthcare (EDQM). Over the course of the 24 month pilot phase, the participants shared their surveillance lists and found 97 sites common to all three regions, resulting in the exchange of nearly 100 inspection reports and in nine collaborative inspections. The FDA used these reports to inform decisions, such as whether to postpone or expedite its own inspection. The FDA also prohibited imports in
'/>"/>

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Intellect Neurosciences, Inc. to Present Data on Alzheimers Vaccine at 13th International Congress of Immunology Conference
2. Paper in International Journal of Oncology Reports Alfacells ONCONASE(R) Suppresses Intracellular Oxidative Stress
3. Ozarelix Phase 2 Data Presented at 29th Congress of the Societe Internationale dUrologie
4. Anadys Pharmaceuticals Presents Preclinical Results on ANA598, a Non-Nucleoside Inhibitor of the NS5B Polymerase, at the 14th International Symposium on Hepatitis C Virus and Related Viruses
5. International Expert Group Initiates Largest Multi-center Phase III Trial to Evaluate NeuroAid(TM) in Stroke Recovery
6. Surface Logix Presents Positive Phase 1 Repeat-Dose Trial Data on SLx-4090 at The 16th International Symposium on Drugs Affecting Lipid Metabolism
7. Preclinical Data on Lead MEK Inhibitor, RDEA119, to be Presented at the 2007 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics
8. Tumor Growth Inhibition and Pharmacokinetic Profile of NKTR-102 (PEG-Irinotecan) in Multiple Solid Tumors To Be Presented at Upcoming AACR-NCI-EORTC International Conference
9. Preimplantation Genetic Diagnosis International Society Refutes American Society of Reproductive Medicine Opinion - States Preimplantation Genetic Screening is Beneficial When Performed in Experienced Centers
10. Survival Data for Avicenas Amyotrophic Lateral Sclerosis Drug Candidate, AL-02, to be Presented at 18th International Symposium on ALS/MND
11. CEL-SCI CEO to Present at the International Society for Pharmaceutical Engineering 2007 Chesapeake BioShowcase
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/25/2014)... 25, 2014 Research and Markets ... Diagnostic Devices Market 2014-2018" report to their offering. ... About Ophthalmic Diagnostic Device An ophthalmic ... a defect or deficiency in the human visual pathway. ... such as presbyopia, cataracts, glaucoma, retinal disorders, conjunctivitis, and ...
(Date:7/25/2014)... Ore. , July 25, 2014  Semler ... an emerging medical risk assessment company that develops ... patients and evaluating chronic diseases, today reported financial ... ended June 30, 2014. "The ... for Semler," said Doug Murphy-Chutorian , M.D., ...
(Date:7/25/2014)... , July 25, 2014  Arena Pharmaceuticals, Inc. ... provide a corporate update and report second quarter 2014 ... on Friday, August 1, 2014. That same day, Arena ... a.m. Eastern Time (5:30 a.m. Pacific Time). ... 877.643.7155 for domestic callers and 914.495.8552 for international callers. ...
Breaking Medicine Technology:Global Ophthalmic Diagnostic Devices Market 2014-2018: Key Vendors are Alcon, Carl Zeiss, Haag-Streit and Topcon 2Semler Reports Second Quarter 2014 Financial Results 2Semler Reports Second Quarter 2014 Financial Results 3Arena Pharmaceuticals to Host Corporate Update and Financial Results Conference Call and Webcast on Friday, August 1 2Arena Pharmaceuticals to Host Corporate Update and Financial Results Conference Call and Webcast on Friday, August 1 3
... 10, 2011 Sildenafil, a drug used to ... possible use -- helping children and young adults ... Sildenafil significantly improved measures of exercise performance during ... according to researchers from The Children,s Hospital of ...
... seek ways to reduce Medicaid spending, they should start by ... model to the more efficient model used in some parts ... finds that the program could save $473 million over ... more like those in Medicare and commercial plans. Governors Chris ...
Cached Medicine Technology:Exercise Performance in Children and Young Adults with Single Ventricle Heart Disease Improves with Use of Drug for Erectile Dysfunction 2Exercise Performance in Children and Young Adults with Single Ventricle Heart Disease Improves with Use of Drug for Erectile Dysfunction 3Budget Solution? Modernizing Medicaid Pharmacy Could Save Florida $473 Million 2
(Date:7/26/2014)... WA (PRWEB) July 26, 2014 “Healthy teeth ... in keeping those pearly whites shining,” says Community Health Center ... Teeth Healthy ." , They believe that an integration of ... people healthy and well. Because of this, they encourage regular ... also with dentist . , “Children and adults will ...
(Date:7/26/2014)... OH (PRWEB) July 26, 2014 The U.S. ... guidelines list that includes a new medication guide for AndroGel ... a serious side-effect of taking the topical low testosterone medication, ... that AbbVie Inc., the makers of the low testosterone theapy ... symptoms of pain, swelling or redness as signs of a ...
(Date:7/26/2014)... WA (PRWEB) July 26, 2014 According ... by Vkool.com, this is a comprehensive guide that covers ... (KP) effectively without the need of any medication. ... book consists of natural and safe remedies for relieving ... book, people will learn:,     How to ...
(Date:7/25/2014)... UK (PRWEB) July 26, 2014 Dental ... variety of dental services including general dentistry, clear braces ... opening in September this year in Derby. The new ... at the HollyBrook Medical Centre in Littleover, Derby. Patients ... new practice. , The new dental practice, which is ...
(Date:7/25/2014)... Los Angeles, CA (PRWEB) July 25, 2014 ... to talk about, and eager to reverse the symptoms associated ... health in the media at large, a new case ... the real benefits of testosterone therapy using bioidentical ... Jason, a 38-year-old father from Seattle who found himself beginning ...
Breaking Medicine News(10 mins):Health News:Common Dental Care Questions Answered by Community Health Center of Snohomish County in Recent Article 2Health News:FDA Updates AndroGel Risks to Include Blood Clots In Legs and Lungs as Testosterone Treatment Lawsuits Move Forward 2Health News:FDA Updates AndroGel Risks to Include Blood Clots In Legs and Lungs as Testosterone Treatment Lawsuits Move Forward 3Health News:FDA Updates AndroGel Risks to Include Blood Clots In Legs and Lungs as Testosterone Treatment Lawsuits Move Forward 4Health News:FDA Updates AndroGel Risks to Include Blood Clots In Legs and Lungs as Testosterone Treatment Lawsuits Move Forward 5Health News:Banish My Bumps Pdf Review Exposes Angela Steinberg's Keratosis Pilaris Treatment Plan – Vkool.com 2Health News:Banish My Bumps Pdf Review Exposes Angela Steinberg's Keratosis Pilaris Treatment Plan – Vkool.com 3Health News:Derby Cosmetic Dentist Dental Perfection to Open New Practice in Littleover, Derby this September 2Health News:New Case Study Highlights Effectiveness of Testosterone Therapy in Fighting Weight Gain and Fatigue 2Health News:New Case Study Highlights Effectiveness of Testosterone Therapy in Fighting Weight Gain and Fatigue 3
... . , Quebec City, March 12, 2008A research ... identified genetic markers that allow the selection of eggs ... after in vitro fertilization (IVF). This finding could both ... diminish the risk of multiple pregnancies. The details of ...
... Jon Dobson, of Keele University in Staffordshire, UK, have found, ... in the part of the brain affected by Alzheimer,s Disease ... association was particularly strong in females compared to males. The ... differences in the way the body handles and stores iron. ...
... Keystone and other initiatives are featured, DETROIT, ... provide an inside look at how groundbreaking partnerships,among ... Michigan are,saving lives, improving patient care and reducing ... Blues., "These partnerships demonstrate the powerful, positive ...
... Brand Omeprazole Delayed Release Tablet, 20 mg Delivers the ... but More Cost Effective for ... ALLEGAN, Mich., March 12 Beginning early March ... have a,new treatment option available to them as retailers ...
... Tooth enamel losses, found in 30% of middle schoolers ... WEDNESDAY, March 12 (HealthDay News) -- Dental erosion -- ... on the increase in the United States, researchers say. ... suspicions of the high prevalence of dental erosion in ...
... on Breast MRI, There is ... Imaging, NEWPORT NEWS, Va., March 12 ... Director of The Eisenhower,Medical Center in Rancho Mirage, ... the need for biopsy after,an indeterminate MRI, thereby ...
Cached Medicine News:Health News:Researchers develop a method to select eggs with the best chance of leading to successful pregnancy 2Health News:Increased level of magnetic iron oxides found in Alzheimer's disease 2Health News:Partnerships Report Highlights How Blue Cross Blue Shield of Michigan, Physicians and Hospitals Are Working to Save Lives, Improve Care, Reduce Costs 2Health News:Partnerships Report Highlights How Blue Cross Blue Shield of Michigan, Physicians and Hospitals Are Working to Save Lives, Improve Care, Reduce Costs 3Health News:Partnerships Report Highlights How Blue Cross Blue Shield of Michigan, Physicians and Hospitals Are Working to Save Lives, Improve Care, Reduce Costs 4Health News:First Over-The-Counter Store Brand Omeprazole Offering in U.S. Market Creates New Option for Frequent Heartburn Sufferers 2Health News:First Over-The-Counter Store Brand Omeprazole Offering in U.S. Market Creates New Option for Frequent Heartburn Sufferers 3Health News:Dental Erosion on Rise in U.S. 2Health News:Radiologist Leora Lanzkowsky Study Suggests ... 2
... applier consists of an applier shaft with attached ... titanium clips. , ,The clip applier jaw ... structure. As the handles of the applier are ... vessel or structure. As the handles are released, ...
... Utilizing a disposable loading unit, the LDS-2™ instrument ... tissue within the cartridge jaw and the knife ... clips. The instrument is activated by squeezing the ... go. The size of the clip is determined ...
... LIGACLIP Clip Applier is a reusable instrument ... clips. This instrument is used with LIGACLIP ... either 316L stainless steel or titanium. The ... tubular structures where a nonabsorbable ligating device ...
SM&trade Single Use Loading Unit with 35 staples available in regular and wide sizes....
Medicine Products: