Navigation Links
MDS Reports Third Quarter 2007 Results
Date:9/6/2007

red of them by the FDA. To date, we have been in contact with sponsors responsible for approximately 85% of the 217 ANDA submissions under review. Based on our communication with customers and on the work done at our facility since January, 150 ANDA submissions have been subjected to third party audits. The FDA imposed a six-month time limit on completing this work in their January 10, 2007 letter to ANDA sponsors and we therefore believe that substantially all of site audit work for these ANDA studies has now been done. Most of our efforts at this time are focused on follow-up questions and supporting the finalization of our customers' remaining audit reports.

In addition to generic studies, the FDA has requested information regarding submitted NDA applications for innovative drugs that contain data from bioanalytical studies conducted from January 2000 to December 2004 in our St. Laurent and Blainville, Quebec facilities. As of today it is difficult to estimate the full extent of the FDA's intent relative to innovator studies. To August 29, 2007, we had assisted on 38 study audits for a smaller number of NDA submissions for which the FDA has requested additional review.

Also during the quarter, we continued to respond to questions from customers and from European regulators about the nature of the work being done for the FDA. At this time, we are not able to assess the impact of possible European regulatory actions. We are working closely with these regulators to address their questions utilizing work prepared in the FDA review.

During the second quarter, we approved and recorded a $61 million provision for a reimbursement policy for clients who have incurred or will incur third party audit costs to complete the work required by the FDA and other regulators. During the third quarter, we utilized $5 million of this reserve for such costs. Based on information currently available, we believe that the existing provision will be sufficient to cover a
'/>"/>

SOURCE MDS Inc.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33

Related medicine news :

1. Autopsy reports could be valuable and informative
2. China reports declining number of SARS Cases
3. Russia Reports First SARS Case
4. Research reports that c-section deliveries are rising
5. Jharkhand reports 13,000 Malaria cases
6. Uganda Reports Failure To Contain Sleeping Sickness
7. WHO reports 36 million deaths world wide due to chronic diseases
8. Reports of Hantavirus infection in India raise concerns
9. Controversy Surrounding The HIV Positive Reports Of One-Year Girl In Kerala
10. China Reports Yet Another Bird Flu Case
11. China reports seventh bird flu victim
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/31/2015)... ... , ... Sculpted Contours Luxury Medical Aesthetics announces the arrival of the newest ... this new applicator in the United States as an upgrade to the CoolSmooth applicator ... original applicator required a 2 hour treatment time. The new CoolSmooth Pro reduces ...
(Date:7/31/2015)... ... July 31, 2015 , ... Jacksonville-based drug and alcohol rehabilitation ... Conference Center. The medical community, social workers, law enforcement, and government officials are ... in the effort to better understand and combat sex trafficking. Lead by sex ...
(Date:7/31/2015)... ... July 31, 2015 , ... Coco Libre announced today that ... and VIPs at the 2015 Vans US Open of Surfing, July 25 through August ... claim “no added sugar” on the market, is a natural choice given the Open’s ...
(Date:7/31/2015)... ... July 31, 2015 , ... Ticket Down is a reliable ... looking to catch a new and refreshing show on Broadway, look no further than ... including an Obie Award, Outer Critics Circle Award, Drama Desk Award, Lucille Lortel Award, ...
(Date:7/31/2015)... ... , ... According to an article published July 2 on Healio, ... a consensus on the steps that need to be taken to successfully complete several ... consensus on a series of steps that each surgeon must complete for each procedure. ...
Breaking Medicine News(10 mins):Health News:Cooler Coolsculpting in Atlanta: Treatments Now Twice As Fast 2Health News:Cooler Coolsculpting in Atlanta: Treatments Now Twice As Fast 3Health News:Lakeview Health Links Sex Trafficking and Addiction in Special Jacksonville Educational Workshop 2Health News:Lakeview Health Links Sex Trafficking and Addiction in Special Jacksonville Educational Workshop 3Health News:Coco Libre Brings Eco-conscious Hydration to Vans US Open of Surfing 2Health News:Cheap Hamilton Tickets at Richard Rodgers Theatre: Ticket Down Slashes Ticket Prices for Hamilton in New York City at the Richard Rodgers Theatre 2Health News:Cheap Hamilton Tickets at Richard Rodgers Theatre: Ticket Down Slashes Ticket Prices for Hamilton in New York City at the Richard Rodgers Theatre 3Health News:Cheap Hamilton Tickets at Richard Rodgers Theatre: Ticket Down Slashes Ticket Prices for Hamilton in New York City at the Richard Rodgers Theatre 4Health News:Cheap Hamilton Tickets at Richard Rodgers Theatre: Ticket Down Slashes Ticket Prices for Hamilton in New York City at the Richard Rodgers Theatre 5Health News:Cheap Hamilton Tickets at Richard Rodgers Theatre: Ticket Down Slashes Ticket Prices for Hamilton in New York City at the Richard Rodgers Theatre 6Health News:Cheap Hamilton Tickets at Richard Rodgers Theatre: Ticket Down Slashes Ticket Prices for Hamilton in New York City at the Richard Rodgers Theatre 7Health News:Article on Plastic Surgery Consensus Highlights the Duties of Veteran Plastic Surgeons, says Beverly Hills Physicians 2Health News:Article on Plastic Surgery Consensus Highlights the Duties of Veteran Plastic Surgeons, says Beverly Hills Physicians 3
... Should be considered along with LDL cholesterol ... 12 (HealthDay News) -- A new study showing ... of cardiac trouble strengthens the case for including ... , "Triglycerides traditionally have been viewed as second-class ...
... Global Trends, Progress and ... ANNAPOLIS, Md., Feb. 12 iJET Intelligent ... business resiliency services,today announced the publication of 2007 ... by iJET,s health intelligence team, the report,provides analysis ...
... CHICAGO (February 12, 2008) A new study published in ... of Surgeons shows that patients with a large support network ... prior to having a surgical procedure, which can have a ... findings suggest that it is important for clinicians to be ...
... of Frozen Desserts Nationwide Fuels ... Cefiore,s ... and one of the nation,s fastest-growing frozen yogurt,destinations, introduced today its ... 90% of U.S. households consuming frozen,desserts and many choosing frozen yogurt ...
... 12 Natural,Alternatives International, Inc. ("NAI") (Nasdaq: ... customized nutritional,supplements, today announced the appointment of Kenneth ... Mr. Wolf possesses over 20,years of manufacturing and ... as Chief Financial Officer with Phoenix Footwear Group, ...
... AKRON, Ohio, Feb. 12 Planning for the WKDD ... progressing effortlessly,when a company backed out at the last ... listening to the radio at just the right,moment., ... to WKDD, and [on-air personality] Matt Patrick was,discussing a ...
Cached Medicine News:Health News:Triglycerides Linked to Coronary Disease Risk 2Health News:Triglycerides Linked to Coronary Disease Risk 3Health News:iJET Unveils 2007 Year-in-Review Report on Avian Influenza and Pandemic Planning 2Health News:iJET Unveils 2007 Year-in-Review Report on Avian Influenza and Pandemic Planning 3Health News:Patients with larger social networks may fare better after an operation 2Health News:Latest Salvo Fired in Frozen Yogurt Wars as Southern California's Fastest-Growing Franchise - Cefiore - Launches New Chocolate Flavor 2Health News:Natural Alternatives International, Inc. Appoints New Chief Financial Officer 2Health News:Natural Alternatives International, Inc. Appoints New Chief Financial Officer 3Health News:Virtual Hold Technology Donates Toys, Helps Raise Money for WKDD's Annual Radiothon for Akron Children's Hospital 2
(Date:7/30/2015)... -- Today we bring you a special edition of #MedicareMonday on Medicare,s 50 th ... our Medicare resources and continue highlighting the success of the prescription drug benefit, commonly ... Check out our latest infographics and videos here: http://onphr.ma/1INp9qQ ... ... ...
(Date:7/30/2015)... 2015  Amgen (NASDAQ: AMGN ) today ... 2015. Key results include: , Total revenues ... 2014 to $5,370 million, with 6 percent product ... (etanercept), Prolia ® (denosumab), Sensipar ® ... (denosumab). Unfavorable changes in foreign exchange rates ...
(Date:7/30/2015)... July 30, 2015 Tianyin Pharmaceutical Inc. (NYSE ... that specializes in the patented biopharmaceutical, modernized traditional Chinese ... provided updates regarding the notice it received on May ... indicating that the Company was below certain of the ... 134 and 1101 of the NYSE MKT Company Guide, ...
Breaking Medicine Technology:Happy 50th Anniversary Medicare! 2Happy 50th Anniversary Medicare! 3Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 2Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 3Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 4Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 5Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 6Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 7Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 8Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 9Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 10Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 11Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 12Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 13Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 14Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 15Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 16Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 17Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 18Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 19Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 20Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 21Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 22Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 23TPI Provides Update Regarding Non-Compliance with NYSE MKT Continued Listing Requirements 2
... Inc. (NYSE: WPI ) today announced that ... with Endo Pharmaceuticals, Inc. on outstanding patent litigation related ... its lawsuit on March 4, 2010, following Watson,s filing ... U.S. Food and Drug Administration (FDA) for seeking approval ...
... Inc. (Nasdaq: AKRX ) will host a conference ... results followed by a Q&A session.  The company will release ... Akorn Third Quarter 2010 Conference CallDate/Time: , Tuesday, November ... (888) 215-6895International Callers: , (913) 312-0860Confirmation Code: , ...
Cached Medicine Technology:Watson Reaches Settlement with Endo Over Opana® ER 2
0.5 mm, 1 x 2 teeth set at 45 degrees and 6 mm tying platform. Serrated handle with polished finish....
5 mm tying platform, serrated cross action handle with polished finish. Teeth: 0.10 mm, 1 x 2 set at 90 degrees....
Colibri style tips with 0.12 mm, 1 x 2 teeth. Round knurled handle with alignment pin and polished finish....
0.12 mm, 1 x 2 teeth set at 45 degrees with 6 mm tying platform. Wide serrated handle with polished finish....
Medicine Products: