Navigation Links
Appraisal of FDA’s Drug Safety Proces

A team of experts criticized Food and Drug Administration (FDA) for not being able to effectively track the safety of new drugs and take action promptly for problems.//

The Institute of Medicine’s report probably will strengthen the discussion on the safety of the country’s drug supply and the competence of the FDA.’s supervision. A serious discussion began in September 2004 when Merck removed its popular arthritis drug, Vioxx, after long-term use was associated with an increased risk of heart attack and stroke.

At the request of the FDA, the Institute of Medicine, a nonprofit organization formed by Congress to advise the federal government on health issues, conducted the study. According to the Institute of Medicine more funds, people and power are required in FDA to ensure it upholds focus on the safety of the drugs it regulates throughout the time they are on the market. Cultural modifications are also required to prevent the tensions that can upset the evaluation of drugs' risks and benefits.

Labeling and advertising restrictions on newly approved drugs are also needed to emphasize the doubts that remain about their safety, according to the institute in "The Future of Drug Safety," a report issued Friday.

According to the institute, a catastrophe in drug safety seemed to have appeared.

"We found an imbalance in the regulatory attention and resources available before and after approval," said Sheila Burke, chairwoman of the committee that wrote the report. "Staff and resources devoted to pre-approval functions are substantially greater. Regulatory authority that is well-defined and robust before approval diminishes after a drug is introduced to the market."

"Nor does FDA have the resources to keep up once the drugs reach the market in assessing safety or informing the public about any risks that might develop.

"I am committed to taking additional steps and will look to the initiatives recommen
'"/>




Page: 1 2 3

Related medicine news :

1. Tissue implant scandal heightens FDA’s concer
2. First Implantable artificial heart gets FDA’s approva
3. New standards for Human Research Safety
4. Safety of soy under suspicion
5. The Safety Of Prenatal Ultrasounds Questioned
6. Report on the Safety and Effectiveness of Melatonin supplements
7. Monitoring Drug Safety
8. Safety Of Indian Sex Workers At Risk Due To Poor Condom Usage
9. Safety Of Heart Drug Questioned
10. Race Was Used To Determine Safety Of Blood
11. Patient Safety Forces Closure Of Hospital
Post Your Comments:
*Name:
*Comment:
*Email:
TAG: Appraisal FDA Drug Safety Proces

(Date:5/2/2015)... (PRWEB) May 02, 2015 “ Peachtree ... its monthly Tech Report, which features the latest and ... technology expert and special reporter for NewsWatch, conducted the ... high-end audio equipment. , Music is an important ... should be pampered and given the royal treatment. Peachtree ...
(Date:5/2/2015)... 02, 2015 As a nonsurgical ... of the face, neck and décolleté, radiofrequency energy ... real potential for the success of vulvovaginal rejuvenation. ... Clinical Advisory Council, ThermiGyn’s Women’s Health Clinical Advisory ... concluded that ThermiGyn’s temperature controlled radio frequency, specifically ...
(Date:5/1/2015)... IDLife LLC, a health and wellness ... the addition of its newest partner and fitness celebrity, ... athlete, growing up in gymnastics and competitive diving, but ... a personal trainer and helping others achieve their fitness ... TV shows highlighting her stunning physique and unique training ...
(Date:5/1/2015)... May 01, 2015 Jusuru International has ... the successful repositioning of its flagship nutritional supplement, Liquid ... with a new name, new logo, new packaging, new ... Awards are designed to identify and promote programs that ... , “DSA congratulates Jusuru International for their outstanding ...
(Date:5/1/2015)... Costa Mesa, CA (PRWEB) May 01, 2015 ... sponsor at the Cerner Southeast Regional User Group (RUG) ... 2015. The Cerner Southeast Regional User Group Conference provides ... access to vendors who support all aspects of electronic ... innovative use of Cerner software applications. , In addition ...
Breaking Medicine News(10 mins):Health News:Affordable High-End Audio Equipment was Featured on NewsWatch Television 2Health News:Study Demonstrates Efficacy of Temperature Controlled Radiofrequency for Vulvovaginal Laxity 2Health News:Study Demonstrates Efficacy of Temperature Controlled Radiofrequency for Vulvovaginal Laxity 3Health News:IDLife LLC Announces New Partnership with Fitness Celebrity, Jen Widerstrom 2Health News:Jusuru International Receives 2015 DSA Ethos Award 2Health News:Jusuru International Receives 2015 DSA Ethos Award 3Health News:Jusuru International Receives 2015 DSA Ethos Award 4Health News:Jusuru International Receives 2015 DSA Ethos Award 5Health News:TROY Healthcare to Exhibit at the Cerner Southeast Regional User Group Conference 2Health News:TROY Healthcare to Exhibit at the Cerner Southeast Regional User Group Conference 3
... CARY, N.C., Sept. 22 The North Carolina Dental Society (NCDS) ... excellence in dental health promotion to the public. , , ... state dental association that most effectively improves awareness of oral health ... informational program associated with the North Carolina Missions of Mercy (NCMOM) ...
... , NEW YORK, Sept. 22 ... annual Scientific Research Grants Program. , , ... organization dedicated to finding cures for peripheral neuropathies--awards two ... period. , , This year,s ...
... , WASHINGTON, Sept. 22 The City of Newark, New ... America,s pharmaceutical research and biotechnology companies. The program is designed to ... who do not qualify for Medicaid. , ... its member companies are proud to be able to work with Newark ...
... , , SILVER SPRING, Md., Sept. ... of personal emergency response buttons worn around the neck of a ... (Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO ) , , ... and 2009 of serious injury or death, including three deaths in ...
... , , , DES PLAINES, ... the corporate supporters for the 2009 ENA Annual Conference to be ... This year,s Annual Conference Sponsors are Ethicon, Inc., GE ... West and Gebauer Company. , , "We are ...
... , HUNTINGTON BEACH, Calif., Sept. 22 ... 2009 at 9 AM at the Huntington Beach Pier. , ... walk to raise funds for the National Alliance on Mental Illness - ... this event will be used to serve the needs of local individuals ...
Cached Medicine News:Health News:Neuropathy Association Research Grants Advance the Understanding of Diabetic Neuropathy and Autoimmune Neuropathies 2Health News:Pharmaceutical, Biotech Research Companies Support Newark Rx Assistance Program 2Health News:Pharmaceutical, Biotech Research Companies Support Newark Rx Assistance Program 3Health News:FDA: Philips Lifeline Issues Safety Alert for Lifeline Pendant Personal Help Buttons 2Health News:Emergency Nurses Association Announces Corporate Supporters for 2009 Annual Conference 2Health News:NAMI-OC 5K Walk Funds Free Mental Health Programs in Orange County 2
(Date:4/30/2015)... CITY, Calif., April 30, 2015 Abaxis, Inc. ... point-of-care blood analysis systems, today reported financial results for ... 2015. Fourth quarter and fiscal 2015 overview: ... for the fourth quarter, up 33% over last year,s ... 25% year-over-year. , Diluted EPS of $0.50 for ...
(Date:4/30/2015)... 2015  Tandem Diabetes Care ® , Inc. (NASDAQ: ... t:slim ® and t:flex™ Insulin Pumps, today reported its ... In comparing the first quarter of 2015 to ... percent to $12.3 million from $8.1 million , t:slim ... pumps "Our investment in resources to build the ...
(Date:4/30/2015)... 30, 2015  DURECT Corporation (Nasdaq: DRRX ) ... 2015.  Total revenues were $4.8 million and net loss ... 31, 2015 as compared to total revenues of $6.3 ... three months ended March 31, 2014.At March 31, 2015, ... to cash and investments of $34.9 million at December ...
Breaking Medicine Technology:Abaxis Reports Financial Performance for the Fourth Quarter and Fiscal 2015 and Declares a 10% Increase in Quarterly Cash Dividend 2Abaxis Reports Financial Performance for the Fourth Quarter and Fiscal 2015 and Declares a 10% Increase in Quarterly Cash Dividend 3Abaxis Reports Financial Performance for the Fourth Quarter and Fiscal 2015 and Declares a 10% Increase in Quarterly Cash Dividend 4Abaxis Reports Financial Performance for the Fourth Quarter and Fiscal 2015 and Declares a 10% Increase in Quarterly Cash Dividend 5Abaxis Reports Financial Performance for the Fourth Quarter and Fiscal 2015 and Declares a 10% Increase in Quarterly Cash Dividend 6Abaxis Reports Financial Performance for the Fourth Quarter and Fiscal 2015 and Declares a 10% Increase in Quarterly Cash Dividend 7Abaxis Reports Financial Performance for the Fourth Quarter and Fiscal 2015 and Declares a 10% Increase in Quarterly Cash Dividend 8Abaxis Reports Financial Performance for the Fourth Quarter and Fiscal 2015 and Declares a 10% Increase in Quarterly Cash Dividend 9Abaxis Reports Financial Performance for the Fourth Quarter and Fiscal 2015 and Declares a 10% Increase in Quarterly Cash Dividend 10Abaxis Reports Financial Performance for the Fourth Quarter and Fiscal 2015 and Declares a 10% Increase in Quarterly Cash Dividend 11Abaxis Reports Financial Performance for the Fourth Quarter and Fiscal 2015 and Declares a 10% Increase in Quarterly Cash Dividend 12Abaxis Reports Financial Performance for the Fourth Quarter and Fiscal 2015 and Declares a 10% Increase in Quarterly Cash Dividend 13Abaxis Reports Financial Performance for the Fourth Quarter and Fiscal 2015 and Declares a 10% Increase in Quarterly Cash Dividend 14Abaxis Reports Financial Performance for the Fourth Quarter and Fiscal 2015 and Declares a 10% Increase in Quarterly Cash Dividend 15Abaxis Reports Financial Performance for the Fourth Quarter and Fiscal 2015 and Declares a 10% Increase in Quarterly Cash Dividend 16Abaxis Reports Financial Performance for the Fourth Quarter and Fiscal 2015 and Declares a 10% Increase in Quarterly Cash Dividend 17Abaxis Reports Financial Performance for the Fourth Quarter and Fiscal 2015 and Declares a 10% Increase in Quarterly Cash Dividend 18Abaxis Reports Financial Performance for the Fourth Quarter and Fiscal 2015 and Declares a 10% Increase in Quarterly Cash Dividend 19Abaxis Reports Financial Performance for the Fourth Quarter and Fiscal 2015 and Declares a 10% Increase in Quarterly Cash Dividend 20Abaxis Reports Financial Performance for the Fourth Quarter and Fiscal 2015 and Declares a 10% Increase in Quarterly Cash Dividend 21Abaxis Reports Financial Performance for the Fourth Quarter and Fiscal 2015 and Declares a 10% Increase in Quarterly Cash Dividend 22Abaxis Reports Financial Performance for the Fourth Quarter and Fiscal 2015 and Declares a 10% Increase in Quarterly Cash Dividend 23Abaxis Reports Financial Performance for the Fourth Quarter and Fiscal 2015 and Declares a 10% Increase in Quarterly Cash Dividend 24Tandem Diabetes Care Reports First Quarter 2015 Financial Results 2Tandem Diabetes Care Reports First Quarter 2015 Financial Results 3Tandem Diabetes Care Reports First Quarter 2015 Financial Results 4Tandem Diabetes Care Reports First Quarter 2015 Financial Results 5Tandem Diabetes Care Reports First Quarter 2015 Financial Results 6DURECT Corporation Announces First Quarter 2015 Financial Results and Update of Programs 2DURECT Corporation Announces First Quarter 2015 Financial Results and Update of Programs 3DURECT Corporation Announces First Quarter 2015 Financial Results and Update of Programs 4DURECT Corporation Announces First Quarter 2015 Financial Results and Update of Programs 5DURECT Corporation Announces First Quarter 2015 Financial Results and Update of Programs 6DURECT Corporation Announces First Quarter 2015 Financial Results and Update of Programs 7DURECT Corporation Announces First Quarter 2015 Financial Results and Update of Programs 8
Bipolar semi-floating pacing lead for temporary stimulation of the heart especially in emergency cases of bradycardial arrhythmias or for recording intracardiac ECGs....
Unipolar Ventricular Lead...
The Guidant Fineline II Sterox is a steroid-eluting pacing lead designed for permanent implantation for either atrial or ventricular applications....
The Vitatron Brilliant S+ lead series are endocardial leads designed for the Vitatron VDD pacemaker systems offering optimal atrial sensing, superior handling and excellent pacing characteristics....
Medicine Products: