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FDA encourages ophthalmic product sponsors to start with human testing in U.S.
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ORLANDO, Fla. — Because of current state of onerous federal regulations, many companies begin human testing of new ophthalmic products outside the U.S. But a representative from the U.S. Food and Drug Administration suggested here that beginning such tests in the United States can save time.
The FDA is in the process of wrapping up guidelines to walk product industry sponsors through the process step-by-step.
"I would like to encourage all of you who are that early in development to call us, e-mail us, come in because you will be shocked, sometimes it is easier to do it in the U.S.," Malvina B. Eydelman, MD, director of the FDA's Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices, said at the Ophthalmology Innovation Summit. "And you won't have to deal with the consequences of doing the trial internationally without getting FDA input and then trying to bring that data into US because that very often has its own inherent issues."
Dr. Eydelman noted that studies done outside the U.S. are in many cases acceptable for approval in the U.S., but that testers need to be highly aware of how the study is conducted to ensure it is applicable in the United States.
Studies must take into account the population demographics and the standard of care is identical, for example, she said.
The Ophthalmology Innovation Summit (OIS) cites as its mission to unite "leaders in the development of ophthalmic products, drugs, and devices." The Ophthalmology Innovation Summit was held one day prior ot the American Academy of Ophthalmology.
- Disclosure: Dr. Eydelman is the director of the FDA's Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices.