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Corporate Integrity Agreements: A Year in Review

WEBIntroduction. In 2021, the Department of Health and Human Services Office of Inspector General (HHS-OIG) entered into 30 new corporate integrity agreements …

Actived: 1 days ago

URL: https://www.skadden.com/insights/publications/2022/02/corporate-integrity-agreements-a-year-in-review

HHS-OIG Year in Review: Pharma and Medical Device CIAs …

WEBCorporate integrity agreements (CIAs) continued to be an important tool for the Office of Inspector General, U.S. Department of Health and Human Services (HHS …

Category: Health Go Health

FDA’s Final Rule on Intended Use: ‘Getting Right Back to Where …

WEBOn August 2, 2021, the U.S. Food and Drug Administration (FDA) issued its final rule amending the intended use regulations codified at 21 CFR 801.4 and 21 CFR 201.128, …

Category: Food Go Health

Life Sciences and Health Care

WEBSkadden is consistently ranked as a leading firm for Healthcare in Chambers USA and for Life Sciences by The Legal 500 U.S. We have been recognized among the top firms for …

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DOJ’s Evolving Enforcement Approach to Off-Label Promotion

WEBIn part two of our series on recent settlements between DOJ and FDA-regulated drug and medical device manufacturers, we look at DOJ’s evolving …

Category: Medical Go Health

Reductions in Force: Legal Do’s and Don’ts

WEBReductions in force can be accomplished through voluntary employment terminations (such as offering early retirement incentives), involuntary terminations or …

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Return-to-Office Update and Considerations for Employers

WEBWe highlight key labor considerations and changes, from updated federal guidance to developing legal standards, in light of the recent surge of COVID-19 cases, …

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EU and Germany Lay Groundwork for the Use of Medical Data for …

WEBNew legislation and other initiatives by the EU and Germany aim to accelerate and centralize the digitization of health care data, both to protect privacy and stimulate …

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The Implications of HHS-OIG’s New General Compliance Program …

WEBOn December 5, Skadden presented the webinar “The Implications of HHS-OIG’s New General Compliance Program Guidance for Life Sciences Companies.”

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Trends in Corporate Integrity Agreements

WEB4 Skadden, Arps, Slate, Meagher & Flom LLP and Affiliates Trends in Corporate Integrity Agreements Re˜ect New S OI uidance on se of xclusion Authority Contacts John T. …

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Medicare and Medicaid Developments in Health Care Bankruptcies

WEBIn 2019, the increased wave of distressed health care companies continued, and with downward pressure on reimbursement rates, regulatory changes, decreased …

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Iora Health To Be Acquired by 1Life Healthcare News & Rankings

WEBWith 22 offices, more than 1,700 attorneys and 50-plus practice areas, Skadden advises businesses, financial institutions and governmental entities around the …

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FREQUENTLY ASKED QUESTIONS FOR COVERED ENTITIES

WEB12/23/21 1 frequently asked questions for covered entities order of the commissioner of health and mental hygiene to require covid-19 vaccination in the workplace

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Joint Promotional Programs With Physicians Raise Compliance Risks

WEBThe fifth installment of our Enforcement in Life Sciences series highlights in-kind transfers between companies and physicians that may raise compliance issues and …

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FDA Issues Guidance on Prescription Drug Sample Distribution …

WEBOn June 8, 2020, the Food and Drug Administration (FDA or Agency) issued temporary guidance to address concerns related to distribution of drug samples during the COVID …

Category: Food Go Health

Considerations for Continuing To Work From Home During COVID …

WEBAs it becomes clear that working from home was not just for the initial period of lockdown but is likely to continue for at least the duration of the COVID-19 pandemic, …

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Privacy & Cybersecurity Update Insights Skadden, Arps, Slate

WEBIn our April Privacy & Cybersecurity Update, we review Washington state’s new health data privacy law, California’s finalized CCPA regulations, an HHS notice

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Novartis’ $678 Million Settlement Sets Guideposts for Life Sciences

WEBNovartis Pharmaceuticals Corporation 1 (Novartis) recently entered into a civil settlement agreement with the Department of Justice (DOJ) to resolve allegations …

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Stuart N. Alperin Professionals Skadden, Arps, Slate, Meagher

WEBWith 22 offices, more than 1,700 attorneys and 50-plus practice areas, Skadden advises businesses, financial institutions and governmental entities around the world on their …

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HKEx Reforms Attract High-Profile Technology and Biotech …

WEBSkadden, Arps, Slate, Meagher & Flom LLP and Affiliates skadden.com HKEx Reforms Attract High-Profile Technology and Biotech Listings In the past year, nearly a dozen …

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Volume 255—No . 62 friday, april 1, 2016 Labor reLations …

WEBthe layoffs. The U.S. Court of Appeals for the Second Circuit reversed the district court’s order dismissing the case and found there was a dispute of material fact regarding …

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