Regulatory/Legislative News

Ocular Therapeutix has resolved a warning letter from the FDA regarding requirements of the premarket approval application for ReSure Sealant, according to a press release.

President Donald J. Trump’s recent executive order to ensure the production of essential medicines in the United States and cut down on the country’s reliance on foreign production of medical supplies drew mixed reactions from experts.

Allergan intends to withdraw application filings for abicipar pegol in Europe and Japan, according to a press release from Molecular Partners.

The Trump administration filed a brief with the Supreme Court on Thursday night to overturn the Affordable Care Act.

A Supreme Court decision Thursday allowed the Deferred Action for Childhood Arrivals, or DACA, program to remain in effect, keeping the approximately 690,000 offspring of U.S. immigrants from being deported.

A judge in the U.S. Court of Appeals blocked HHS from implementing a rule requiring drug companies to put the manufacturer’s list price for prescription drugs or biological products to wholesalers or direct purchasers in TV commercials.

The HHS announced that it has finalized a rule that allows the government to interpret sex discrimination based on the definition of the word “sex” as male or female and biology — a move the agency also said “protects and enforces the civil rights of all.”

The United States, the United Kingdom, Chile, Germany and Italy have proposed using “immunity passports” as a potential strategy for easing physical distancing measures, according to a paper published in The Lancet. However, a bioethics expert told Healio Primary Care that there are too many barriers for governments to implement them.

CMS recently announced a second round of regulatory waivers and rule changes to expand care to the nation’s seniors and provide health care systems flexibility.

Innovative new technology has always been part of what makes ophthalmology an exciting specialty — and it has undeniably improved patient outcomes. But for surgeons who are early adopters, the flip side of being first is that one must also weather some financial uncertainties as new technologies, such as minimally invasive glaucoma surgery, corneal collagen cross-linking and sustained-release drugs, establish a solid reimbursement footing.