MoFo Life Sciences

March 30, 2023 - COVID-19, FDA, Healthcare, Regulatory, Digital Health, Medical Devices + Diagnostics, United States
FDA Issues Final Transition Guidances for COVID-19 Devices
By: Stacy Cline Amin, Brigid DeCoursey Bondoc and Keunbong (KB) Do
This week, the U.S. Food & Drug Administration (FDA) issued two much anticipated guidances, each outlining how COVID-19 devices will be treated after the expiration of the COVID-19 public health emergency (PHE) declaration or termination of the COVID-19 Emergency Use Authorization (EUA) declarations: 1)
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March 29, 2023 - Digital Health, FDA, Healthcare, Regulatory, United States
FDA Publishes Digital Health Technology Framework
By: Stacy Cline Amin and Brigid DeCoursey Bondoc
On Thursday, March 23, 2023, the Food and Drug Administration (FDA) announced the publication of the “ Framework for the Use of Digital Health Technologies in Drug and Biological Product Development ” (Framework) by the Center for Drug Evaluation and Research (CDER) and the
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March 24, 2023 - Pharma, Healthcare, United States
CMS Announces Part B Prescription Drugs with Lower Coinsurance Amounts for Q2 2023
By: Stacy Cline Amin and Wendy C. Chow
The Inflation Reduction Act of 2022 requires drug companies to pay rebates to Medicare when prescription drug prices increase faster than the rate of inflation for certain drugs. This inflation rebate applies to Medicare Part B rebatable drugs, which are single-source drugs and biological
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March 21, 2023 - European Union, FDA, Medical Devices + Diagnostics, Healthcare, Regulatory
Eu Mdr and Ivdr Implementation: New Transitional Regime Enters Into Force
By: Robert Grohmann
On March 20, 2023, the new transitional regime for medical devices in the EU and the EEA became effective when Regulation (EU) 2023/607 (the “ Regulation ”) was published in the Official Journal of the European Union. The Regulation provides for highly anticipated extensions
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March 13, 2023 - Healthcare, Litigation, Intellectual Property, United States
Don’t Cry Over Spilled Milk: Federal Circuit Finds Milk Vitamin Patent Invalid
By: Meghan McLean Poon and Josephine A. Garban
In ChromaDex Inc. v. Elysium Health Inc. ,[1] the Federal Circuit found U.S. Patent No. 8,197,807 (the “’807 patent”), which is directed to a dietary supplement comprising an isolated vitamin, invalid for lack of subject matter eligibility under 35 U.S.C. § 101. ChromaDex, a
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March 01, 2023 - Healthcare, Pharma, Regulatory, Litigation, United States
States Extend Scope of Regulatory Oversight of Health Care Entities
By: Wendy C. Chow
The proliferation of private investor-backed management of health care practices continues to draw scrutiny from regulators into the impact on patient care, health care costs, and access to services. State regulators play a key role in monitoring and challenging anticompetitive behavior at the local
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February 28, 2023 - Healthcare, Pharma, Litigation, Regulatory, United States
CMS Releases Guidance on the Medicare Prescription Drug Inflation Rebate Program
By: Wendy C. Chow
The Inflation Reduction Act of 2022 (IRA) was signed into law on August 16, 2022 and includes several provisions to lower prescription drug costs for Medicare beneficiaries and reduce drug spending by the federal government. One provision of the IRA requires drug manufacturers to
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February 16, 2023 - COVID-19, United States, FDA, Medical Devices + Diagnostics, Healthcare, Pharma
Ending the COVID-19 Public Health Emergency – What Happens Next
By: Stacy Cline Amin, Wendy C. Chow and Keunbong (KB) Do
The Biden administration announced on January 30, 2023, that it plans to terminate the COVID-19 public health emergency declaration (the “PHE declaration”) on May 11, 2023. COVID-19 EUA medical products and policies As FDA has clarified in its draft transition guidance for medical devices
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February 08, 2023 - Privacy + Data Security, Pharma, Healthcare, United States, Digital Health
FTC Brings First Enforcement Action of the Health Breach Notification Rule
By: Melissa M. Crespo
The Federal Trade Commission (FTC) has enforced its Health Breach Notification Rule (the “HBNR”) for the first time since it was enacted in 2009. On February 1, the FTC announced a first-of-its-kind proposed order (the “Order”) with digital health platform GoodRx Holdings Inc. (“GoodRx”),
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February 07, 2023 - FDA, Regulatory, Pharma, Healthcare, United States
Supreme Court Denies Review of Cost Sharing Assistance Program
By: Stacy Cline Amin, Adam L. Braverman, Wendy C. Chow, Will Baker and Seth W. Lloyd
The U.S. Supreme Court recently declined to review a Second Circuit decision that blocked Pfizer from implementing a cost sharing assistance program. Pfizer had sought to cover out-of-pocket expenses for financially eligible Medicare patients who need tafamidis, the only approved drug by the Food
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