CMS Reveals New Details on Medicare Drug Price Negotiation Program
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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.
- 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... ›
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... ›FDA Enables Pharmacies to Dispense Abortion-Inducing Mifepristone in Revised REMS
By: Stacy Cline Amin, 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... ›Privacy Litigation 2022 Year in Review: Biometric Information Privacy Act (BIPA)
By: Tiffany Cheung
In 2022, Illinois’s Biometric Information Privacy Act (BIPA) litigation was bustling. Defendants in BIPA cases ranged from pharmacies, insurance companies, and social media platforms to software companies, schools, and airlines. Even with the steady stream of opinions in 2022, key questions about BIPA’s scope... ›Congress Expands FDA Authority Over Cosmetics
By: Stacy Cline Amin, Brigid DeCoursey Bondoc and Matt Robinson
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was passed by the U.S. Congress as part of the omnibus Consolidated Appropriations Act enacted on December 29, 2022 and will grant the U.S. Food and Drug Administration (FDA) significant new authority to regulate cosmetics.... ›FDA Clarifies the Human Factors or Usability Information to Include in a Device Marketing Submission
By: Stacy Cline Amin, Brigid DeCoursey Bondoc and Keunbong (KB) Do Ph.D.
Brandy Guarda, Regulatory Analyst in Washington, D.C., contributed to the drafting of this post. If you are a device manufacturer, what human factors and usability information should you include in your marketing submission? What if your device has the same user interface as an existing... ›EU MDR and IVDR Implementation: Signs of Relaxing Transitioning Regime and Bridging Measures
By: Wolfgang Schönig and Robert Grohmann
Concerns over possible medical device shortages in the EU have led to two recent developments that will affect the implementation of the Medical Device Regulation [1] ( MDR ) and In Vitro Diagnostic Medical Device Regulation [2] ( IVDR ) : The EU Employment,... ›AI Trends for 2023 - FDA Regulatory
In September 2022, the U.S. Food & Drug Administration (FDA) released its Clinical Decision Support (CDS) Software Guidance and the final report on the Software Pre-Certification Pilot Program. The new FDA policies move away from prized flexibilities in the previous guidelines governing software products.... ›Relabeling vs. Repackaging: CJEU Backs Drug Manufacturers’ Position Against Parallel Importers
By: Robert Grohmann
In two recent landmark decisions, Novartis v. Abacus (C ‑ 147/20) and Bayer v. kohlpharma (C-204/20), the Court of Justice of the European Union ( CJEU ) strengthened the position of drug manufacturers against repackaging practices of parallel importers. The court held that, based... ›FDA Final Food Traceability Rule: Overview and Key Takeaways from FDA’s Food Safety Modernization Act Webinar
By: Stacy Cline Amin
Food Traceability Final Rule Overview On November 21, 2022, the U.S. Food and Drug Administration (FDA) officially published its Final Rule: Requirements for Additional Traceability Records for Certain Foods (“Final Rule”) in the Federal Register. The Final Rule establishes additional traceability recordkeeping requirements for... ›