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 an
'/>"/>

SOURCE GlaxoSmithKline
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2

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:7/25/2014)... As reported by People Magazine in the article Mike ... Sober (7/15), one of the most popular cast stars ... the public about his personal transformation. Now, two years later ... moving on with his life was a challenge. He was ... 2012 and even spent some time in rehab. He took ...
(Date:7/25/2014)... July 25, 2014 Merrill Corporation ... technology-enabled services for the financial, legal, healthcare and ... data room business, Merrill DataSite, has been recognized ... by GrowthBusiness at the M&A Awards 2014 event. ... achievements of entrepreneurs, management teams, advisors and financiers ...
(Date:7/25/2014)... Ticket Down is a reliable source for cheap ... California Memorial Stadium. With the post-World Cup emotions still rolling ... the 2014 Guinness International Champions Cup have brought eight of ... representing La Liga, English Premier League, Serie A, and Superleague ... players from around the world to 12 American cities and ...
(Date:7/25/2014)... nearly 27,000 older adults on five continents found that ... on a simple test that measures how fast people ... tested positive for pre-dementia were twice as likely as ... led by scientists at Albert Einstein College of ... Center , was published online on July 16, 2014 ...
(Date:7/25/2014)... July 25, 2014 As thousands of ... U.S. courts, Bernstein Liebhard LLP notes that the Food ... the consumer advocacy group, Public Citizen, to order a ... letter dated May 1, 2014, and released to the ... petition for a ban on the marketing of all ...
Breaking Medicine News(10 mins):Health News:'The Situation' Celebrates 8 Months of Sobriety 2Health News:'The Situation' Celebrates 8 Months of Sobriety 3Health News:Merrill DataSite Recognized as “Technology Provider of the Year” by GrowthBusiness at the M&A Awards 2014 Event 2Health News:Real Madrid vs. Inter Milan Tickets Berkeley: Ticket Down Slashes Ticket Prices on Guinness International Champions Cup Tickets at California Memorial Stadium 2Health News:Real Madrid vs. Inter Milan Tickets Berkeley: Ticket Down Slashes Ticket Prices on Guinness International Champions Cup Tickets at California Memorial Stadium 3Health News:Slow walking speed and memory complaints can predict dementia 2Health News:Slow walking speed and memory complaints can predict dementia 3Health News:Slow walking speed and memory complaints can predict dementia 4Health News:Transvaginal Mesh Lawsuit News: FDA Rejects Petition Seeking Ban and Global Recall of All Transvaginal Mesh Products, Bernstein Liebhard LLP Reports 2Health News:Transvaginal Mesh Lawsuit News: FDA Rejects Petition Seeking Ban and Global Recall of All Transvaginal Mesh Products, Bernstein Liebhard LLP Reports 3Health News:Transvaginal Mesh Lawsuit News: FDA Rejects Petition Seeking Ban and Global Recall of All Transvaginal Mesh Products, Bernstein Liebhard LLP Reports 4
... known as a common marker of inflammation plays a key ... by Cell Press in the September issue of the journal ... for cancer treatment. , CRP is a protein that is ... of inflammation in response to the inflammatory cytokine IL-6. The ...
... in the skull that detects oncoming seizures, then delivers a ... under study at the Medical College of Georgia. , MCG ... determine if the neurostimulator device can help patients whose seizures ... monitors electrical activity of the brain, gets accustomed to what ...
... Most Parents Take "Wait and See" Approach to ... Schwab Learning,a nonprofit program of the Charles ... children with learning and attention problems,announced today their ... who,suspect their child may have a learning problem. ...
... COLUMBIA, S.C., Sept. 10 Harvard Medical School,researchers ... an,innovation that allows health care providers to obtain ... the pre-certification,process more efficient and less costly. ... Care Policy,selected BlueCross, "Web Precert" tool as one ...
... face time with P&G executives ... and the chance to win $40,000 -, BOSTON, ... to create a buzz for the billion dollar,brand. Known throughout the ... Braun is seeking marketing plans,for its electric shaver business from students ...
... much of their time in the womb bobbing along ... from the Georgia Institute of Technology and Emory University ... under similarly shaky conditions. , Georgia Tech and Emory ... embryonic stem cells in fluid environments, similar to shaking ...
Cached Medicine News:Health News:Human C-reactive protein regulates myeloma tumor cell growth and survival 2Health News:Implantable device designed to detect, stop seizures under study at MCG 2Health News:Schwablearning.Org Launches Interactive Tool to Help Parents of Children Struggling in School 2Health News:Harvard Researchers Select S.C. BlueCross for National Honor 2Health News:Harvard Researchers Select S.C. BlueCross for National Honor 3Health News:Braun Challenges Business School Talent To 'Create A Buzz' 2Health News:Embryonic stem cells thrive when shaken 2
(Date:7/25/2014)... BERWYN, Pa. , July 25, 2014  AMETEK, ... appointment of Kurtis L. Goos as Vice ... Engineered Materials, Interconnects and Packaging (EMIP) Division. ... has extensive general management and business development experience, especially ... to make important contributions to the continued growth and ...
(Date:7/25/2014)... July 25, 2014  Arena Pharmaceuticals, Inc. (NASDAQ: ... corporate update and report second quarter 2014 financial results ... August 1, 2014. That same day, Arena will host ... Time (5:30 a.m. Pacific Time). The ... domestic callers and 914.495.8552 for international callers. Please specify ...
(Date:7/24/2014)...  PTC Therapeutics, Inc. (NASDAQ: PTCT ) ... conference call to report its second quarter 2014 financial ... and outlook on Thursday, August 7, 2014 at 8:30 ... The call can be accessed by dialing ... prior to the start of the call and providing ...
Breaking Medicine Technology:AMETEK Names Kurtis L. Goos, Vice President & General Manager, Engineered Medical Components 2Arena 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
... secret is finally reaching the east coast and all points ... health and beauty boutique named Endless Youth and Life is ... supplement is helping thousands of Americans shed excess abdominal fat ... Just a few capsules per day and their stomachs are ...
... Inc. (NASDAQ: IPHS ) today announced that its ... $0.25 per share of common stock.  The dividend will be ... of the close of business on October 14, 2011. ... American producer of specialty phosphate products, offering performance-critical ingredients with ...
Cached Medicine Technology:Beverly Hills Secret Now Helping People Across The Country 2
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
Medicine Products: