Olive Lee at Akin Gump Strauss Hauer & Feld LLP

HHS to Launch Campaign Promoting Wearable Devices

On June 24, 2025, in a hearing before the U.S. House of Representatives Committee on Energy and Commerce, the Secretary of Health and Human Services (HHS), Robert F. Kennedy Jr. revealed that his department plans to soon...more

6/27/2025 / Advertising , Data Privacy , Data Protection , Department of Health and Human Services (HHS) , Digital Health , Food and Drug Administration (FDA) , Healthcare Reform , Medical Devices , Public Health , Wearable Technology

FDA Announces Commissioner’s National Priority Voucher Program to Accelerate Drug Application Review Process and Support National...

On June 17, 2025, the U.S. Food and Drug Administration (FDA) announced the Commissioner’s National Priority Voucher (CNPV) program, a new program that aims to speed up drug application review for companies aligned with U.S....more

6/23/2025 / Abbreviated New Drug Application (ANDA) , Food and Drug Administration (FDA) , Prescription Drugs , Vouchers

FDA Finalizes Guidance on Communication of Unapproved Uses of Approved or Cleared Medical Products

On January 6, 2025, the FDA released final guidance for industry entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions...more

1/20/2025 / Compliance , Final Guidance , Final Rules , Food and Drug Administration (FDA) , Health Care Providers , Healthcare , Medical Devices , OMB , Pharmaceutical Industry , Regulatory Agenda , Regulatory Reform , Regulatory Requirements

FDA’s Idea Lab Seeks to Reimagine Device Use in the Home Through New Virtual Reality Prototype

On December 30, 2024, FDA unveiled an Idea Lab as part of its Home as a Health Care Hub initiative to reimagine how new and existing medical devices can be incorporated in a home environment. As previously discussed here, FDA...more

1/3/2025 / Food and Drug Administration (FDA) , Home Health Care , Medical Devices , Virtual Reality

FDA Announces Plan to Speed Up Public Notification About Potentially High-Risk Device Recalls

On November 21, 2024, FDA’s Center for Devices and Radiological Health (CDRH) announced a pilot program aimed at improving public notice about potentially high‑risk medical device recalls. The pilot seeks to reduce the time...more

11/26/2024 / Corrective Actions , Federal Pilot Programs , Food and Drug Administration (FDA) , Medical Devices , Notification Requirements , Product Recalls , Public Safety

FDA Approves the First Flu Vaccine for At Home Use, Providing a Needle Free Option Outside of Traditional Health Care Settings

On September 20, 2024, the U.S. Food and Drug Administration (FDA) approved the first influenza (flu) vaccine for at‑home use. The vaccine, FluMist, is administered by nasal spray and prevents the flu by using a weakened...more

11/8/2024 / Food and Drug Administration (FDA) , Healthcare , Vaccinations , Virus Testing

FDA Authorizes Marketing for First Combination Flu and COVID-19 At-Home Test Outside of Emergency Use

On October 7, 2024, FDA granted marketing authorization for the over‑the‑counter combination flu and COVID-19 combination test, Healgen Rapid Check COVID-19/Flu A&B Antigen Test. Although other at‑home combination tests...more

11/8/2024 / Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Health Care Providers , Influenza , Virus Testing

FDA Amplifies Cross-Center Collaboration with the Creation of the Rare Disease Innovation Hub

Roughly one out of every ten people in the United States are affected by rare diseases. Many of these conditions are life‑threatening, and most lack FDA-approved treatments. Developing therapies for rare diseases, however, is...more

11/7/2024 / Center for Biologics Evaluation and Research (CBER) , Center for Drug Evaluation and Research (CDER) , Clinical Trials , Collaboration , Food and Drug Administration (FDA)

Olive Lee

Akin Gump Strauss Hauer & Feld LLP

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