Navigation Links
GlaxoSmithKline Confirms Receipt of FDA Letter on Regulatory Reporting
Date:4/8/2008

LONDON and PHILADELPHIA, April 8, 2008 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) today confirmed it has received a warning letter from the US Food and Drug Administration (FDA) related to reporting requirements for approved medicines. The letter follows a routine FDA inspection of GSK's reporting processes conducted last year.

The observations from the inspection primarily relate to omissions from periodic reports to the FDA regarding Avandia(R) (rosiglitazone maleate), such as the start and progress of clinical trials, and summaries of final data from some clinical trials.

The FDA inspection also reviewed GSK's processes for reporting individual adverse events, which resulted in no inspection citations. The inspection found nothing to suggest that procedures for prompt reporting of adverse events was compromised.

"We take these findings seriously, and corrective steps to make sure we file periodic reports completely and promptly have been taken or are underway," said Dr. Ronald Krall, Chief Medical Officer at GlaxoSmithKline. "These omissions did not interfere with the timely reporting of adverse event information to the FDA."

GSK is committed to taking the appropriate steps to address the concerns raised by the FDA.

After the inspection, GSK initiated a review of applicable processes and reporting systems. The company has made and will continue progress in updating its procedures and improving compliance in this area of reporting, including additional training for employees to ensure that all procedures are followed across all product lines.

The FDA letter acknowledges that information not captured in the periodic reports was, in many cases, submitted to the Agency in other reports and communications. Beyond that, information about the start of clinical trials omitted from some reports was available through posting on clinicaltrials.gov. GSK submitted a corrected 2007 Avandia annual report to the FDA in September 2007, ahead of the FDA's updated final decision on approved labeling for Avandia in November 2007. Clinical trial results are also posted publicly to GSK's clinical trial register.

GlaxoSmithKline -- one of the world's leading research-based pharmaceutical and healthcare companies -- is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, visit GlaxoSmithKline on the World Wide Web at http://www.gsk.com.


'/>"/>
SOURCE GlaxoSmithKline
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. GlaxoSmithKline Responds to JAMA Articles
2. MedImmune Licenses Reverse Genetics Technology to GlaxoSmithKline for Use in Influenza Vaccine Development and Production
3. Congressional Black Caucus Foundation and GlaxoSmithKline Announce Supplier Business Initiative Study Results
4. AUDIO from Medialink and GlaxoSmithKline: A New Nasal Spray for Allergy Relief
5. Mylan Announces Settlement of Paroxetine Hydrochloride Extended-Release Tablets with GlaxoSmithKline
6. GlaxoSmithKline Aids California Fire Relief Efforts
7. Genmab and GlaxoSmithKline Initiate Ofatumumab Rheumatoid Arthritis Phase III Program
8. GlaxoSmithKline Obtains Exclusive U.S. OTC Marketing Rights to MEVACOR(R) (lovastatin) from Merck & Co., Inc.
9. Pharmacopeia and GlaxoSmithKline Collaboration Identifies Two Additional Lead Compounds
10. GlaxoSmithKline Presents Innovative Neuroscience Pipeline
11. GlaxoSmithKline Receives FDA Complete Response Letter for Cervical Cancer Vaccine
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/2/2016)... ... December 02, 2016 , ... ... the launch of its 60-day free trial program for all of the company’s ... the offer a truly hassle free experience. , FlexiSpot’s unique desktop risers use ...
(Date:12/2/2016)... ... December 02, 2016 , ... U.S. Surgeon General, Dr. Vivek Murthy, graces ... explains how he was inspired to practice medicine at an early age by his ... more than making diagnoses and prescribing medicine,” he states. “It is about building relationships ...
(Date:12/2/2016)... ... December 02, 2016 , ... Dr. Raffi Hovsepian, a leading ... the 2016 “Guide to America’s Top Plastic Surgeons” for seven consecutive years. The ... education, experience, and professional associations. , One the most frequently honored surgeons ...
(Date:12/2/2016)... ... December 02, 2016 , ... CloudLIMS.com, ... its SaaS LIMS, CloudLIMS Lite. CloudLIMS Lite helps biobanks, clinical, research and testing ... shipping and disposal. The new version is a faster and a more efficient ...
(Date:12/2/2016)... ... December 02, 2016 , ... Sourced from the Isbre Springs beneath the ... its unmatched natural purity of just 6 ppm TDS (Total Dissolved Solids) in addition ... has been available in several ShopRite and FoodTown stores in NJ and received rave ...
Breaking Medicine News(10 mins):
(Date:12/2/2016)... Dec. 2, 2016 The U.S. Food and ... (empagliflozin) to reduce the risk of cardiovascular death in ... disease. "Cardiovascular disease is a leading ... mellitus," said Jean-Marc Guettier , M.D., C.M., director ... FDA,s Center for Drug Evaluation and Research. "Availability of ...
(Date:12/2/2016)... , December 2, 2016 Persistence ... pacemaker market in its upcoming report titled, "Global Market Study on ... Declining CAGR of -1.4% between 2016 and 2024". The global ... in 2015 and this is likely to decline to ... the global cardiac pacemaker market is anticipated to exhibit ...
(Date:12/2/2016)... NEW YORK , December 2, 2016 ... Market Research titled "Global Market Study on Automated Endoscope Reprocessors: ... Register a CAGR of 8.6% Between 2016 and 2024 " the ... 2015 and is expected to expand at a CAGR of ... market valuation of US$ 1,367.6 Mn by 2024. ...
Breaking Medicine Technology: