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UTI
November 11, 2024
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WikiGuidelines group publishes first new UTI guidance in 14 years

Regulatory/Legislative News

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September 19, 2024
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Regener-Eyes addresses violations cited in FDA warning letter

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.

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June 05, 2024
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VIDEO: Innovation comes from entrepreneurs, physicians in eye care community

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.

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April 30, 2024
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FDA approves preservative-free version of Lumify redness-reliever eye drops

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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UTI
November 11, 2024
3 min read
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WikiGuidelines group publishes first new UTI guidance in 14 years

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April 12, 2024
1 min read
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DOJ files complaint against Regeneron for alleged false drug pricing reports

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.

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February 16, 2024
1 min read
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SightGlass receives FDA breakthrough designation for spectacle lenses that slow myopia

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.

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February 02, 2024
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FDA warns against use of possibly contaminated copycat eye drops

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.

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November 21, 2023
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Kilitch Healthcare India voluntarily recalls OTC eye drop products

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.

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November 17, 2023
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Amazon removes eye drops from website after FDA warning

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.

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May 09, 2023
1 min read
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FDA approves ophthalmic spray for mydriasis

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.

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January 15, 2023
3 min watch
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VIDEO: Congress makes positive adjustments that affect ophthalmologists

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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