Regulatory/Legislative News

The FDA recently issued final guidelines outlining its nonbinding recommendations for safe and secure interactions among medical devices and other information systems, calling for devices to be designed with interoperability as an objective.

Ophthalmic clinical trials of products for diabetic macular edema and Leber’s hereditary optic neuropathy, as well as geographic atrophy and pain and inflammation in cataract surgery, all moved forward in the month of August.

The FDA and the European Medicines Agency have granted orphan drug designation to QRX-421, an investigational drug for Usher syndrome, according to a press release from ProQR Therapeutics.

The rare solar eclipse that passed through the United States in August led ophthalmology-related news for the month, which also included FDA advancements and business updates.

The FDA moved forward on multiple ophthalmology-related products in the month of August. Here are the top five advancements as reported on Healio.com/OSN:

The annual Women in Ophthalmology Summer Symposium will take place in San Diego from Aug. 10 to 13 with a restructured format, new content and more networking opportunities, meeting chair Lisa Nijm, MD, JD, told Healio.com/OSN.

The FDA offices of Orphan Products Development and Pediatric Therapeutics have designated voretigene neparvovec as a drug for a rare pediatric disease, according to a Spark Therapeutics press release.

EvokeDx for objective assessment of central vision function, including the diagnosis of glaucoma, has received a CE mark, according to a press release from Konan Medical.

In this blog from Epstein Becker & Green and its affiliate EBG Advisors, Robert Atlas and Yulian Shtern delve into the upcoming Merit-Based Incentive Payment System and how physicians can best maneuver their way through the process .

The FDA has sent a complete response letter to Ocular Therapeutix saying it cannot approve the Dextenza new drug application “in its present form,” according to a company press release.