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Regulatory/Legislative News
Regener-Eyes addresses violations cited in FDA warning letter
After receiving a warning letter from the FDA on Aug. 16 citing “significant violations” related to two Regener-Eyes ophthalmic products, the company has implemented several improvements to address the concerns.
VIDEO: Innovation comes from entrepreneurs, physicians in eye care community
KIAWAH ISLAND, S.C. — In this Healio Video Perspective from Kiawah Eye, Jeffrey J. Kimbell, president and CEO of Jeffrey J. Kimbell and Associates, explains how the federal government and elections affect the eye care community.
FDA approves preservative-free version of Lumify redness-reliever eye drops
The FDA has approved Lumify Preservative Free eye drops for the treatment of ocular redness due to minor eye irritations, according to a press release from manufacturer Bausch + Lomb.
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DOJ files complaint against Regeneron for alleged false drug pricing reports
The U.S. Department of Justice filed a complaint under the False Claims Act against Regeneron Pharmaceuticals, according to a press release.
SightGlass receives FDA breakthrough designation for spectacle lenses that slow myopia
The FDA has granted breakthrough device designation to SightGlass Vision’s diffusion optics technology spectacle lenses, which are designed to slow myopia progression in children.
FDA warns against use of possibly contaminated copycat eye drops
The FDA has issued a warning to consumers not to purchase or use South Moon, Rebright or FivFivGo eye drops because of possible contamination and risk for eye infection.
Kilitch Healthcare India voluntarily recalls OTC eye drop products
Kilitch Healthcare India Limited has voluntarily recalled 25 over-the-counter eye drop products after the FDA warned of unsanitary conditions and potential safety concerns, according to a company press release.
Amazon removes eye drops from website after FDA warning
After receiving a warning letter from the FDA, the online retailer Amazon removed seven unregulated eye drop products from its website.
FDA approves ophthalmic spray for mydriasis
The FDA has approved Eyenovia’s Mydcombi ophthalmic spray for inducing mydriasis, the company announced in a press release.
VIDEO: Congress makes positive adjustments that affect ophthalmologists
KOLOA, Hawaii — In this Healio Video Perspective from Hawaiian Eye 2023, Kevin J. Corcoran, COE, CPC, CPMA, FNAO, discusses ophthalmic economic and regulatory updates for the year.
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Headline News
Burnout, withdrawal remain ‘alarmingly high’ among physicians and residents
September 17, 20242 min read -
Headline News
Over one-third of adults not planning on receiving recommended vaccines this fall
September 18, 20242 min read -
Headline News
Popular home BP devices unable to provide accurate readings for millions due to sizing
September 19, 20242 min read
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Headline News
Burnout, withdrawal remain ‘alarmingly high’ among physicians and residents
September 17, 20242 min read -
Headline News
Over one-third of adults not planning on receiving recommended vaccines this fall
September 18, 20242 min read -
Headline News
Popular home BP devices unable to provide accurate readings for millions due to sizing
September 19, 20242 min read