Navigation Links
Researchers query FDA about updating requirements for drug approval

Rockville, MD Scientists and the Food and Drug Administration (FDA) are discussing how new technologies in ophthalmology, which make it possible to collect better data about experimental treatments, might affect FDA clinical trials requirements.

Researchers from the National Institutes of Healths National Eye Institute (NEI) and major US universities and research centers met in a roundtable discussion with FDA representatives before an audience of their peers on November 28-29, 2006 in Washington DC.

The discussion among the 30 participants focused on endpoints and clinical trial strategies for evaluating new treatments for age-related macular degeneration (AMD), diabetic retinopathy and other severe retinal disorders.

The exchange is the subject of Report from the NEI/FDA Ophthalmic Clinical Trial Design and Endpoints Symposium, an article in the February 2008 issue of ARVOs peer-reviewed journal, Investigative Ophthalmology and Visual Science ( The authors are Karl G. Csaky of Duke University Medical Center, Elaine A. Richman of Richman Associates and Frederick L. Ferris III, of NEI.

The FDA currently recommends that clinical study sponsors compare changes in visual function (measured on a visual acuity chart of letters and numbers) as a primary endpoint in assessing the effect of a new compound for treating a disorder of the eye.

Many scientists feel that the FDA parameters may not be sensitive enough for studying diseases that progress very slowly or for studying the effect of new anti-VEGF agents for treating AMD. They query whether new technologies could more efficiently detect a treatments effectiveness, thereby hastening the translation of clinical trials into better treatments in the doctors office.

Such new technologies include optical coherence tomography (OCT), a scanning technology that maps, in 3-D, the minute hills and valleys of the retina.

Scientists suggested the FDA consider other endpoints, like OCT-detected changes in the thickness of the retina or the disappearance of problem blood vessels.

The FDA position is firm yet open. FDA representatives reminded researchers that the FDA sets a high bar for new drug approvals.

The agency might consider a lower bar and different endpoints for clinical trials, provided the degree of risk to the patient is correspondingly smaller and the trial sponsor is able to justify the clinical relevance of the new endpoints.

The FDA representatives also explained several new standards for drugs when two products are used in combination (called combination products or multi-agent products).

The report also reflects discussions about drug safety, post-marketing drug surveillance between eye study designs, mechanisms for obtaining and substantiating data for retinal disease post-marketing, and whether statistically significant differences in visual function outcomes are clinically important.


Contact: Joanne Olson
Association for Research in Vision and Ophthalmology

Related medicine news :

1. MITs McGovern Institute researchers awarded $8.5M to study brain basis of autism and dyslexia
2. U of M researchers discover a pathway to turn off immune system cells
3. Oregon researchers find trigger gene for muscle development
4. Researchers uncover more about how poxviruses evade the immune system
5. UCLA researchers discover biomarkers that predict lung cancer patient response to therapy
6. Penn researchers discover new target for preventing and treating flu
7. Researchers investigate links between prostate, cadmium, zinc
8. New nanotube findings by Stanford researchers give boost to potential biomedical applications
9. Researchers Map Paths Governing Neuron Function
10. Cold Spring Harbor Laboratory researchers race against time to save Tasmanian devils
11. Researchers at Peoria Pulmonary Associates to study airway bypass procedure for emphysema
Post Your Comments:
(Date:10/13/2015)... ... , ... Tempe Dental Care, a leading Tempe dentists’ office, celebrates offering gentle, ... for more than 5 years. A leading cause of emergency room visits, school ... is not timely. , Sedation dentistry provides an anxiety-free dental experience ...
(Date:10/13/2015)... ... ... Local Gold’s Gym franchise owner, Bryce Berry, received the Visionary of the ... and operates Gold's Gym Cheyenne in Cheyenne, Wyoming, received the award in ... A brand leader in global fitness, Gold’s Gyms are located worldwide. Every fitness center ...
(Date:10/13/2015)... (PRWEB) , ... October 13, 2015 , ... ... Dr. Bill Saye as the newest professional to introduce the latest development, ThermiVa® ... highly recognized as a leading professional in Obstetrics and Gynecology and a pioneer ...
(Date:10/13/2015)... ... 2015 , ... In an ongoing effort to provide the ... Texas, child development and pediatric therapy center, is working with TRICARE to emphasize ... options for receiving this kind of care for affected children. Because of concerns ...
(Date:10/13/2015)... ... October 13, 2015 , ... Just under three months ago, ... began a $1 promotion – effectively offering all of their services for just a ... the company was flooded with phone calls from interested buyers. As a genuine one-stop-shop ...
Breaking Medicine News(10 mins):
(Date:10/13/2015)... , Oct. 13, 2015 China Jo-Jo ... " China Jo-Jo "), a leading China-based retail, wholesale ... through its own online and retail pharmacies, announced preliminary ... official branded online pharmacy through , growing ... a record 25%. China Jo-Jo,s ...
(Date:10/13/2015)... Oct. 13, 2015  Asterias Biotherapeutics, Inc. (NYSE ... UK-based Cell Therapy Catapult to advance development of ... dendritic cell immunotherapy. Under the agreement, the Cell ... for AST-VAC2 to support advanced clinical trials and ... --> The Cell Therapy Catapult ...
(Date:10/12/2015)...  Former White House Spokesman, and Drug Czar Public Affair ... Committee, Robert Weiner , and Policy Analyst Daniel ... that this is now a potential bipartisan campaign and debate ... , Carly Fiorina to Rand Paul ... which they call "a shocker: 23 million need but do ...
Breaking Medicine Technology: