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Regulatory/Legislative News
FDA approves AcrySof IQ ReSTOR +3.0 D multifocal toric IOL
The FDA has approved Alcon’s AcrySof IQ ReSTOR +3.0 D multifocal toric IOL, according to a company press release.
Symptoms and satisfaction of patients in the PROWL study: Pre- and postoperative legal implications

From international law firm Arnold & Porter LLP comes a timely column that provides views on current regulatory and legislative topics that weigh on the minds of today’s physicians and health care executives.
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Salutaris receives 510(k) clearance for radionuclide brachytherapy device
The FDA has granted 510(k) clearance for the SMD-Sr90-DA Radionuclide Brachytherapy Source, according to a press release from Salutaris Medical Devices.
FDA grants orphan drug designation to miltefosine for Acanthamoeba keratitis
The FDA has designated miltefosine as an orphan drug for the treatment of Acanthamoeba keratitis, according to a press release from Profounda.
EMA accepts application for Oxervate for treatment of neurotrophic keratitis
A registration application for Oxervate eye drops for the treatment of moderate and severe neurotrophic keratitis in adults has been accepted by the European Medicines Agency, according to a Dompé press release.
BLOG: The times they are a changin' — what to watch for in 2017

Eye care has sure seen a lot of changes in 2016, and a look to the year ahead tells us we will probably see more. Here are three continuing trends that are likely to impact the way most of us practice:
FDA approves Restylane products for treating nasolabial folds

Galderma announced it has received FDA approval of two new Restylane products for the treatment of nasolabial folds in patients over the age of 21.
Pharma stocks drop on Trump quote to cut drug prices
Many pharmaceutical stock prices dropped today after President-elect Donald Trump announced in an interview with Time magazine that he will attempt to bring down drug prices during his presidential term.
Ophthalmology reacts to possible ACA, FDA changes under Trump
The shift to a Trump administration could mean several health insurance changes and the strengthening of Medicaid.
FDA clears Navilas 577s
The FDA has granted 510(k) clearance for the Navilas Laser System 577s, a compact, all-digital system for navigated focal and peripheral laser treatments, making it immediately available in the U.S., according to correspondence from OD-OS, the system’s manufacturer.
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Headline News
Senate committee advances NIH, FDA leaders' nominations
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Semaglutide, tirzepatide not deemed cost-effective obesity therapies despite benefits
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Headline News
Senate committee advances NIH, FDA leaders' nominations
March 13, 20252 min read -
Headline News
‘We are going to have difficulty’: Untangling causes of fatigue, long COVID remains elusive
March 14, 20255 min read -
Headline News
Semaglutide, tirzepatide not deemed cost-effective obesity therapies despite benefits
March 14, 20253 min read