Regulatory/Legislative News

Issues observed at Sun Pharma’s Halol facility in Gujarat, India, detailed in an FDA warning letter in December 2015, have been addressed, and the inspection is now closed, according to the company.

Iluvien will receive a partial review of reimbursement guidance from the United Kingdom National Institute for Health and Care Excellence, Alimera Sciences announced in a press release.

The California Optometric Association congratulated Sen. Ed Hernandez, OD, (D) on advancing to the state’s November general election for lieutenant governor.

Eyenovia has received Notices of Allowance from the U.S. Patent and Trademark Office for two patent applications providing coverage on physiologic microdroplet ejection diameters and velocities, according to a press release.

EyeGate Pharmaceuticals has addressed three of the four outstanding action items regarding an FDA investigational device exemption amendment filed for its ocular bandage gel, the company announced in a press release.

The FDA recently filed two complaints in federal court seeking permanent injunctions against two stem cell clinics to stop them from marketing stem cell products without FDA approval, according to a press release.

The California Optometric Association this week cautioned consumers in the state that online vision tests come with significant safety concerns and may appear to violate federal law.

Aerie Pharmaceuticals has submitted a new drug application to the FDA for Roclatan, its once-daily IOP-lowering eye drop, the company announced in a press release.

The American Optometric Association led nearly 500 optometrists and students to Capitol Hill in April to focus its advocacy efforts on federal issues affecting patients and the profession.

The Health Care Alliance for Patient Safety held its “Day on the Hill” with eye care experts from across the U.S. sharing insights and data with policymakers.