Navigation Links
UCSF artificial kidney project tapped for accelerated FDA program
Date:4/9/2012

A UCSF-led effort to create an implantable artificial kidney for dialysis patients has been selected as one of the first projects to undergo more timely and collaborative review at the Food and Drug Administration.

The FDA announced today (April 9) that it had chosen three renal device projects to pilot a new regulatory approval program called Innovation Pathway 2.0, intended to bring breakthrough medical device technologies to patients faster and more efficiently.

The artificial kidney project, which is targeted for clinical trials in 2017, was selected for its transformative potential in treating end stage renal disease and for its potential to benefit from early interactions with the FDA in the approval process.

The FDA effort will involve close contact between the federal agency and device developers early in the development process to identify and address potential scientific and regulatory hurdles and create a roadmap for project approval. The goal is to improve the projects' overall chance of success, while reducing the time and cost of FDA review and maintaining safety. Lessons, the agency said, will inform approvals in other areas.

The artificial kidney project has brought together 40 researchers in nine laboratories nationwide under the guidance of Shuvo Roy, PhD, a bioengineer on the faculty of the UCSF School of Pharmacy. It aims to combine nano-scale engineering with the most recent advances in cellular biology to create an implantable device that would enable patients with chronic kidney failure to lead healthier and more productive lives, without external dialysis or immune suppressant medication.

"The new Pathway program is a clear signal to researchers that innovations in how we treat disease are needed and supported by the FDA," said Mary Anne Koda-Kimble, PharmD, dean of the UCSF School of Pharmacy. "We're so pleased the Kidney Project is in the vanguard as the program launches."

End-sta
'/>"/>

Contact: Kristen Bole
kristen.bole@ucsf.edu
415-502-6397
University of California - San Francisco
Source:Eurekalert  

Page: 1 2

Related biology news :

1. Artificial wetlands can provide benefits over the long haul
2. Artificial womb unlocks secrets of early embryo development
3. Chemists synthesize artificial cell membrane
4. SmartActions Artificial Intelligence IVR Solution Receives PCI Certification
5. Human, artificial intelligence join forces to pinpoint fossil locations
6. NIH awards group $4.5 million for smart artificial pancreas technology
7. Oranges and mandarins are inspected using artificial vision
8. SynCardias Total Artificial Heart Rescues LVAD Patient with Right Ventricular Failure
9. Artificial lung mimics real organs design and efficiency
10. Caltech researchers create the first artificial neural network out of DNA
11. Using artificial, cell-like honey pots to entrap deadly viruses
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
UCSF artificial kidney project tapped for accelerated FDA program
(Date:8/21/2014)... including researchers from the University of Georgia recently published the ... journal Science . Their discovery paves the way for ... farming and industry. , Canola is grown across much ... is increasingly cultivated in Georgia. Canola oil used for cooking ... and rich supply of omega-3 fatty acids, but the plant ...
(Date:8/21/2014)... -- Nxt-ID, Inc. (OTCQB: NXTD), a biometric authentication company ... that its shares of common stock and the warrants ... proposed underwritten public offering of common stock and warrants ... Market, subject to closing of its proposed underwritten public ... trade under the symbol "NXTD" and "NXTDW," respectively. ...
(Date:8/21/2014)... and other itchy, flaky maladies in humans has now ... reefs and the extreme environments of arctic soils and ... journal PLOS Pathogens considers the diversity, ecology, ... Malassezia in light of new insights gained from ... University of Hawai,i at Mānoa scientist Anthony Amend discovered ...
Breaking Biology News(10 mins):Canola genome sequence reveals evolutionary 'love triangle' 2Nxt-ID Approved for NASDAQ Capital Market Listing 2Nxt-ID Approved for NASDAQ Capital Market Listing 3From dandruff to deep sea vents, an ecologically hyper-diverse fungus 2
... Mathematical models have become invaluable decision-making tools for ... Kingdom's foot-and-mouth epidemic of 2001, models can be ... underlying characteristics of an infection and they can ... however, such models make implicit assumptions that may ...
... pandas in California or kangaroos in Argentina. , For David ... a professor of integrative biology at the University of California, ... of a type of salamander that comprises the majority of ... and rare outside the Americas. , "I've discovered and named ...
... have solved the structure of a crucial human immune ... three. In an upcoming issue of the journal Science, ... composed of 23 leucine-rich repeats (LRRs). , The structure ... before, an essential step toward fully understanding the critical ...
Cached Biology News:Understanding biases in epidemic models important when making public health predictions 2Discovery of an American salamander where it shouldn't be: Korea 2Discovery of an American salamander where it shouldn't be: Korea 3Discovery of an American salamander where it shouldn't be: Korea 4Scripps research scientists solve structure of a critical innate immune system protein 2Scripps research scientists solve structure of a critical innate immune system protein 3Scripps research scientists solve structure of a critical innate immune system protein 4
(Date:8/22/2014)... of Surrey have discovered how the receptors responsible for ... , The new study, published today in The ... in turn regulates the cycle of all cells in ... the local biological clock and its control are weakened ... in bladder physiology and ageing. , While ...
(Date:8/22/2014)... York (PRWEB) August 22, 2014 ... of the interesting and challenging endeavors as the ... highly impervious properties to the foreign substances. Ocular ... possibility of self medication and minimal use of ... molecular weight drugs and provides specific targeting within ...
(Date:8/22/2014)... The AMA is pleased to share ... Alaska that Alaska Governor Sean Parnell has signed House ... public use of Unmanned Aircraft Systems and the continuation ... 255states that it is, “An Act relating to unmanned ... unmanned aircraft system.” It defines State of Alaska laws ...
(Date:8/21/2014)... , Aug. 21, 2014  BioSpecifics Technologies ... company developing first in class collagenase-based products marketed ... CCH) in the U.S. and XIAPEX ® ... results from a randomized, double-blind Phase 2a study ... or edematous fibrosclerotic panniculopathy. The results showed that ...
Breaking Biology Technology:Treatment for overactive bladder and irritable bowel syndrome advanced through pioneering research 2Ocular Drug Delivery Technologies Market: Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 - 2020 2Ocular Drug Delivery Technologies Market: Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 - 2020 3Ocular Drug Delivery Technologies Market: Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 - 2020 4State of Alaska Signs Unmanned Aircraft Systems Bill 2BioSpecifics Technologies Corp. Announces Positive Data from Phase 2a Study of CCH for Treatment of Cellulite 2BioSpecifics Technologies Corp. Announces Positive Data from Phase 2a Study of CCH for Treatment of Cellulite 3BioSpecifics Technologies Corp. Announces Positive Data from Phase 2a Study of CCH for Treatment of Cellulite 4BioSpecifics Technologies Corp. Announces Positive Data from Phase 2a Study of CCH for Treatment of Cellulite 5
... stents after opening clogged arteries has led a team of ... in Milwaukee to suggest that stents designed with thinner ... generation of stents. Their findings are published in the July ... , ,One of the most common methods for treating heart ...
... medical profession, one of the greatest obstacles in taking ... that naturally accompanies treatment. Patient histories and care instructions ... if multiple hospitals are involved, more levels of complication ... all this information seems like a Holy Grail, a ...
... of technological innovation sometimes starts out-of-control wildfires of politics, ... IT shop. If youre lucky, youve got some folks ... rapidly shifted from their regular duties to handle the ... reputations are more common results. If youre particularly unlucky, ...
Cached Biology Technology:Medical College discovery leads to new stents 2Human factors and IT: Designing for patient safety 2Human factors and IT: Designing for patient safety 3IT wildfires 2IT wildfires 3
Bethyl Laboratories packages antibodies, conjugates and calibrators to provide quantitative ELISA kits. Each kit contains the following components, sufficient for 1000 single well assays....
Bethyl Laboratories packages antibodies, conjugates and calibrators to provide quantitative ELISA kits. Each kit contains the following components, sufficient for 1000 single well assays....
Request Info...
... and IHC Protocol Development ,Antibody Titer ... in Animal or Human Cells and ... and Tissues ,Peroxidase, Alkaline Phosphatase, Immunogold, ... Electron Microscopy ,Protein Localization in Transgenic ...
Biology Products: