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Regulatory/Legislative News
Case to proceed against clinic for alleged false billing for tonography

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.
Physicians lack clarity on FDA approvals, ‘breakthrough therapy’
Physicians demonstrated limited understanding of the FDA approval process and the meaning of the “breakthrough therapy” designation, according to recent research in JAMA.
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VIDEO: Hot topics in legal, regulatory and payment in ophthalmology
At OSN New York, Allison W. Shuren, MSN, JD, and Candace S. Simerson, COE, CMPE, discuss legal, regulatory and payment topics relevant in ophthalmology.
Senate bill focuses on development of genetically targeted drugs

The U.S. Senate is considering a bipartisan bill intended to speed up the development of genetically targeted drugs for patients with rare life-threatening or debilitating conditions.
Senate committee proposes more efficient approval of medical devices

The U.S. Senate Committee on Health, Education, Labor and Pensions favorably reported legislation that would streamline the FDA’s evaluation process for medical devices, one of seven biomedical innovation bills currently advancing to the full Senate for consideration.
Senate committee proposes updates to FDA application requirements for reusable devices

In a recent session, the Senate Committee on Health, Education, Labor and Pensions favorably reported a bill requiring manufacturers of reusable medical devices to submit cleaning instructions and validation data to the FDA before bringing these devices to market. The bill also would require the FDA to develop guidance on when manufacturers should seek clearance from the agency before marketing their products.
Senate Health Committee passes Advancing Research for Neurological Diseases Act of 2015

The Senate Health Committee passed the “Advancing Research for Neurological Diseases Act of 2015” (S. 849)” on Tuesday, which will establish a national surveillance system for neurological diseases. The full Senate will now consider the bill.
Senate health committee passes Next Generation Researchers Act

The Senate health committee passed the Next Generation Researchers Act (S. 2014) with bipartisan support on Tuesday, which aims to increase opportunities for young researchers and attract them to the NIH. The full Senate will now consider the bill.
Senate: Health care IT bill will ‘end unfair practices’ for patients, providers

The U.S. Senate Committee on Health, Education, Labor and Pensions unanimously recommended a measure designed to improve health care information technology.
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Headline News
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Headline News
FDA issues limited acne product recalls, AAD releases statement on benzoyl peroxide
March 13, 20254 min read -
Headline News
Sleep duration a predictor of high blood pressure in teens regardless of insomnia
March 14, 20252 min read -
Headline News
Additional support may be key to combat shortages in nephrology workforce
March 10, 20257 min read