Navigation Links
New drug development still takes 8 years despite faster FDA review, according to Tufts CSDD
Date:1/8/2009

BOSTON Jan. 8, 2009 While the U.S. Food and Drug Administration Drug has quickened review and approval of new medicines, the complex nature of diseases for which new therapeutics are being developed has resulted in longer clinical development times, according to the Tufts Center for the Study of Drug Development.

The average time for the FDA to approve new drugs declined to 1.1 years in the 2005-07 period, but longer average clinical phase time means combined clinical and approval time continues to hover around eight years, according to Tufts CSDD.

"Even though the total time to bring new drugs to market has remained essentially unchanged in recent years, drug developers are making progress," said Tufts CSDD Director Kenneth I Kaitin, who made his comments in connection with the release today of the Tufts Center's Outlook 2009 report on pharmaceutical and biopharmaceutical trends.

"Many factors are leading to longer clinical times, including a focus on complex diseases and more complicated development design protocols," he added.

Drug companies have taken steps to speed clinical development, according to Kaitin, including improving project management, expanding use of partnerships and licensing arrangements, and increasing use of surrogate endpoints and adaptive clinical trials.

"Still, in drug development, the raceand rewardsgo to the swiftest and most efficient drug sponsors, those that can deliver safe and effective new medicines in the shortest time," he said.

Among the near-term trends cited in the Tufts CSDD's Outlook 2009 report are the following:

  • Firms will continue globalization of their preclinical and clinical development activities to overcome local capacity constraints, increase speed-to-market, and expand their presence in emerging markets.

  • Continued shortages of experienced personnel, especially among upper level managerial staff, will continue to hamper the FDA
    '/>"/>

Contact: Charlene Neu
617-636-2187
Tufts University, Health Sciences
Source:Eurekalert

Page: 1 2

Related medicine news :

1. Isolation of a new gene family essential for early development
2. Therap Services Continues to Hire Experienced Developmental Disability Industry Clinicians for its Customer Support Team
3. The Philadelphia Walk Now for Autism Expected to Draw 10,000 Walkers and Raise $1 Million to Help Find Answers About the Nations Fastest-Growing Developmental Disorder
4. Ovation further advances development pipeline with new phase III epilepsy study
5. Pioneer Surgical Technology Hires Vice President of New Business Development
6. Bridgetech Announces Addition of the Agency for Healthcare Research and Quality as Content Provider in its Development of a Healthcare Web Portal in China
7. Bioniche Receives $2 Million Government Grant For Market Development Related to its E. coli O157:H7 Cattle Vaccine
8. DTI Medical Corporation Announces Reverse Split and Other Corporate Developments
9. Optim To Assist Prairie Community Health Center with Construction Scope Development
10. Nick Childs Joins Grey New York as Director of Content Development
11. New clues to breast cancer development in high-risk women
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/18/2015)... Lower-auto-insurance.com has released a new blog post ... quotes . , Drivers can find accurate information ... professional insurance brokerage website can help drivers compare the ... convenient way. The whole process is designed to be ... online car insurance quotes is advantageous because it allows ...
(Date:4/18/2015)... In the past few weeks, TheBeautyPlace.com has been ... had to run maintenance on our shipping facilities to ... the PR Director. "It disrupted our regular shipping schedule ... back on track after having completed the maintenance." , ... systems which has not allowed some calls to come ...
(Date:4/18/2015)... NE (PRWEB) April 18, 2015 ... in healthcare staffing, including physical therapy jobs, has ... at the South Carolina Physical Therapy Association Annual ... the Kroc Center in Greenville, SC. , ... opportunities, and exhibits with products and services. ...
(Date:4/18/2015)... French physician and gastronome Anthelme Brillat-Savarin understood the ... “Tell me what you eat, and I will tell ... stress or sadness has often been attributed to women, ... collected from their Emotional Eating Test reveals ... for different reasons. , Collecting data from 521 emotional ...
(Date:4/17/2015)... (PRWEB) April 18, 2015 Rosetta Radiology ... facility, rounding out their list of diagnostic imaging services. ... for patients on the Upper East Side of Manhattan. ... at full capacity. The addition of PET-CT, combined with ... physicians the ability to work with patients through several ...
Breaking Medicine News(10 mins):Health News:Auto Insurance Quotes Can Provide Accurate Results! 2Health News:TheBeautyPlace.com Temporary Number Available 2Health News:Healthcare Staffing Leader, Aureus Medical Group, to Exhibit at the South Carolina Physical Therapy Association Annual Conference 2Health News:It’s Not Just A Girl Thing: Queendom Study Reveals That Men Struggle With Emotional Eating Too 2Health News:It’s Not Just A Girl Thing: Queendom Study Reveals That Men Struggle With Emotional Eating Too 3Health News:It’s Not Just A Girl Thing: Queendom Study Reveals That Men Struggle With Emotional Eating Too 4Health News:It’s Not Just A Girl Thing: Queendom Study Reveals That Men Struggle With Emotional Eating Too 5Health News:It’s Not Just A Girl Thing: Queendom Study Reveals That Men Struggle With Emotional Eating Too 6
... ... cooking recipes with only one vegetable, as part of her support of the international ... ... Oxfam Ambassador Kylie Kwong is challenging Australians to imagine life cooking recipes with only ...
... ... introduction of the iPad - medical. Dubai Podiatry Centre is leading the healthcare field in ... is using the new iPads to show detailed structure of the foot and ankle to ... ...
... 58 percent , SUNDAY, May 30 (HealthDay News) -- ... undergo three-dimensional external-beam radiation therapy may be at increased ... action to strengthen their bones after treatment. , Doctors ... bones in men. And three-dimensional external-beam radiation therapy appears ...
... reduce discomfort, scientists say , SUNDAY, May 30 ... may help relieve pain by triggering a natural painkilling ... The researchers also believe they can enhance acupuncture,s effectiveness ... -- deoxycoformycin -- that maintains adenosine levels longer than ...
... in the University of Alberta,s Faculty of Rehabilitation Medicine ... more effective treatments for spinal-cord injuries. Karim Fouad and ... self-repair mechanisms that kick in after injury. To ... important to first describe the neurons in the spinal ...
... ... Great Audio Experience, the first-of-its-kind in Singapore, held to commemorate World No Tobacco Day 2010. ... Singapore (Vocus), May 30, ... from the Students, Health Survey (SHS) 2009 signal a downward trend in youth smoking, with ...
Cached Medicine News:Health News:Kylie Kwong & Oxfam's Recipe to Stop Hunger 2Health News:Kylie Kwong & Oxfam's Recipe to Stop Hunger 3Health News:Dubai Podiatry Centre Becomes the Gulf Region's First Clinic to Bring Apple iPads to the Healthcare Field 2Health News:Radiation for Prostate Cancer May Boost Fracture Risk 2Health News:Acupuncture May Trigger Natural Painkiller 2Health News:U of A discovery offers promising research for spinal-cord injury treatments 2Health News:National Smoking Control Campaign 2010 2Health News:National Smoking Control Campaign 2010 3Health News:National Smoking Control Campaign 2010 4
(Date:4/17/2015)... , April 17, 2015 Today, ... honored 13 employees from 12 biopharmaceutical companies as ... efforts in policy advocacy and community service. ... Health Champion Awards were created by the biopharmaceutical ... excelled in their careers, but have also shown ...
(Date:4/17/2015)... 17, 2015 Sigma-Aldrich Corporation ... and High Technology company, today announced the opening ... headquarters and state-of-the-art Cell Culture Technical Center in ... will provide customized support to meet customer needs, ... "Our new Technical Center will significantly enhance ...
(Date:4/16/2015)... April 16, 2015 A drug commonly taken to ... people with multiple sclerosis (MS), according to a study released ... Neurology,s 67th Annual Meeting in Washington, DC ... half of people with MS experience at some point in ... the nerve carrying vision from the eye to the brain ...
Breaking Medicine Technology:PhRMA Applauds 2015 We Work For Health Champion Award Winners 2PhRMA Applauds 2015 We Work For Health Champion Award Winners 3Sigma-Aldrich Expands Customer-Centric Model with Investments in Singapore That Localize World-Class Capabilities to Better Support Customers in Asia 2Sigma-Aldrich Expands Customer-Centric Model with Investments in Singapore That Localize World-Class Capabilities to Better Support Customers in Asia 3Sigma-Aldrich Expands Customer-Centric Model with Investments in Singapore That Localize World-Class Capabilities to Better Support Customers in Asia 4Sigma-Aldrich Expands Customer-Centric Model with Investments in Singapore That Localize World-Class Capabilities to Better Support Customers in Asia 5Epilepsy Drug May Preserve Eyesight for People with MS 2
... Korea, May 11, 2011 CrystalGenomics, Inc., a biopharmaceutical ... that the draft Clinical Study Report (CSR) from CG400549,s ... been received. CG400549 is a potential first-in-class ... a critical enzyme in generating bacterial membrane and has ...
... Accuray Incorporated (Nasdaq: ARAY ), a global ... 85 percent of European CyberKnife® centers are performing prostate ... increasing trend towards treating prostate cancer patients with a ... of our CyberKnife patients are being treated for prostate ...
Cached Medicine Technology:CrystalGenomics Completes Phase I MAD Study of its Novel Antibiotic Candidate CG400549, and Prepares for Phase II Clinical Study 285 Percent of CyberKnife® Sites Within Europe Performing Prostate Stereotactic Body Radiation Therapy (SBRT) 285 Percent of CyberKnife® Sites Within Europe Performing Prostate Stereotactic Body Radiation Therapy (SBRT) 3
... manufactures its signature line of award-winning flip-up ... These next generation loupes feature extremely ... and are multi-coated lens for anti-glare, anti-fog, ... Sport frame offers a stylish, yet comfortable ...
... first manufacturer to offer through-the-lens (TTL) ... These next generation loupes feature extremely ... design, and are multi-coated lens for ... SheerVision's proprietary SureFit system - you ...
Adjustable Velcro© closures at crown and behind the neck distinguish this immediate post-op face and chin garment for maximum support and compression....
Very compressive support for submental liposuction...
Medicine Products: