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MoFo Life Sciences shares timely legal and business insights and in-depth analyses on trends and the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.

February 16, 2023 - COVID-19, United States, FDA, Medical Devices + Diagnostics, Healthcare, Pharma
Ending the COVID-19 Public Health Emergency – What Happens Next
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 - FDA, Pharma, Medical Devices + Diagnostics, Rare Disease, United States
FDORA Passage Brings Significant Changes to FDA’s Drug, Device, and Cosmetic Authorities
By: Brigid DeCoursey Bondoc
The Consolidated Appropriations Act for 2023 was signed into law on December 29, 2022 and includes the Food and Drug Omnibus Reform Act (FDORA). FDORA authorizes a variety of new and important amendments to the Food, Drug, and Cosmetic Act (FDCA) governing drugs, medical
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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: Adam L. Braverman 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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February 06, 2023 - Healthcare, Litigation, Antitrust, United States
DOJ Signals Intent to Increase Antitrust Scrutiny of Information Sharing
By: Alexander Okuliar, Lisa M. Phelan, Joseph Charles Folio III and Margaret A. Webb
On February 2, 2023, the Principal Deputy Assistant Attorney General for the U.S. Department of Justice’s (DOJ) Antitrust Division, Doha Mekki, announced that the DOJ was withdrawing three policy statements outlining safe harbors for information sharing in the healthcare industry, and suggested that DOJ’s
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January 30, 2023 - FDA, Regulatory, United States, Healthcare, Medical Devices + Diagnostics, Pharma
FTC Issues Updated Health Products Claims Guidance
By: Julie Y. Park, Brigid DeCoursey Bondoc and Matt Robinson
On December 20, 2022, the Federal Trade Commission (FTC) issued its Health Products Compliance Guidance (“Health Products Guidance”). This is the first update in nearly 25 years to FTC’s guidance regarding advertising claims for dietary supplements, foods, over-the-counter drugs, and other health-related products. The
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January 24, 2023 - FDA, Regulatory, United States, COVID-19, Medical Devices + Diagnostics
FDA Updates COVID-19 Testing Guidances
By: Brigid DeCoursey Bondoc
Brandy Guarda, Regulatory Analyst in Washington, D.C., contributed to the drafting of this post. UPDATE : The Executive Office of the President announced on January 30, 2023, that the current administration plans to terminate the PHE declaration on May 11, 2023. This announcement does
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January 20, 2023 - Healthcare, United States, Pharma, Litigation, Regulatory
CMS Reveals New Details on Medicare Drug Price Negotiation Program
For the first time in history, the Centers for Medicare and Medicaid Services (CMS) will engage in price negotiations with drug manufacturers for a subset of high-cost, name-brand drugs covered by Medicare. Pursuant to the Inflation Reduction Act (IRA), CMS took its first steps
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January 18, 2023 - European Union, Medical Devices + Diagnostics
EU MDR and IVDR Implementation: European Commission Publishes Full Proposal for Amending Transitional Regime
By: Wolfgang Schönig and Robert Grohmann
Following up on its announcement in the EU Employment, Social Policy, Health and Consumer Affairs Council ( EPSCO ) Meeting, the European Commission ( Commission ) released on January 6, 2023, a proposal ( Proposal ) to amend the transitional regime under the Medical
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January 17, 2023 - FDA, Regulatory, United States, Pharma
FDA Enables Pharmacies to Dispense Abortion-Inducing Mifepristone in Revised REMS
By: Brigid DeCoursey Bondoc and Kate Driscoll
On January 3, 2023, the U.S. Food & Drug Administration (FDA) modified the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program to remove the in-person dispensing requirement and allow dispensing of mifepristone at certified retail pharmacies. FDA announced this forthcoming modification in December 2021
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