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EW SHOW DAILY 32 ASCRS Symposia Monday, May 9, 2016 Every application is looked at on its own merits and based on what's submitted, Dr. Chambers said. Dr. Eydelman said there are 2 different kinds of applications her division looks at. If it's a Class 2 device, you have to show substantial equivalence, she said. For premarket approval, each product stands on its own. A member of the audience asked about products approved in Europe, specifically how data from Euro- pean trials can be used in the U.S. approval process. Dr. Eydelman said that an application can be provided solely on outside the U.S. data. But she said to be sure the population is the same, and the medical therapies associated with the device would need to be the same. Dr. Eydelman noted that she thinks it's easier today to come to the U.S. first and get a new technol- ogy approved rather than using data from outside the U.S. On the drug side, Dr. Chambers said his response would be the same with 2 exceptions. There is a clause that says we have to be able to accept the data without inspection so it must be sufficiently complete so an inspector wouldn't need to be sent out, he said. Additionally, there is a special consideration particularly for antibacterial-like products be- cause the resistance patterns are not the same throughout the world. "We will want at least 1 study to be done within the U.S. to get a feel for the resistance patterns to see if it matches the U.S. population," he said. EW Editors' note: The speakers have no financial interests related to their comments. by Ellen Stodola EyeWorld Senior Staff Writer trying to get to market. You need to know what kind of indication for use you want to get on label, she said. Frequently, people have the concept for a device but don't really know what they want to demon- strate, she added. "You need to fig- ure out what your ultimate goal is." The second pearl that Dr. Eydelman offered was to come in and talk with the FDA early on. "Most people don't realize that we have an incredible amount of institutional knowledge," she said. Although information on competi- tors cannot be shared, she said that advice can be offered based on previ- ous submissions. "Pre-submission is an incredible opportunity," she said. Dr. Chambers also offered his advice. His first suggestion was to make the application as clearly writ- ten as you can, meaning you could hand it to colleagues to read and they would understand what you intend to do. If they can't, it's likely the agency won't understand either, he said. "And we'll continue to ask questions about it," he said. The sec- ond pearl Dr. Chambers offered was that it's often better to submit an IND with what you want to do and let the agency respond to it. Dr. Afshari asked about compa- nies that apply with similar products and data and how the FDA looks at them differently. T his year's symposium spon- sored by the ASCRS FDA Committee addressed a number of issues involving drug and device combina- tion products. Natalie Afshari, MD, San Diego, moderated the session with Malvina Eydelman, MD, director, Division of Ophthalmic and Ear, Nose & Throat Devices with the Food and Drug Administration (FDA), and Wiley Chambers II, MD, deputy director, Division of Transplant and Ophthal- mology Products, Center for Drug Evaluation and Research with the FDA. Both Dr. Eydelman and Dr. Chambers gave presentations focusing on the process for getting combination products approved in their respective divisions, particular- ly highlighting the Investigational New Drug (IND) approval process. Dr. Afshari asked Dr. Eydelman and Dr. Chambers to share their top 2 pearls of wisdom to try to expe- dite the approval process. Many companies are small, Dr. Afshari said, and the cost of waiting longer for approval could potentially be unbearable for them. Dr. Eydelman said that especial- ly for device companies, it's im- portant to start thinking very early on, from the time of conception of the idea, about what exactly you're FDA symposium highlights drug and device approval process Join the conversation: #ASCRSASOA2016 Dr. Eydelman speaks at the FDA symposium. Dr. Afshari moderates the FDA symposium.

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