Melissa Levine

Jan 9, 2024 | lexology.com | Heidi Forster Gertner |Melissa Bianchi |Robert Church |Melissa Levine |Blake Wilson

The U.S. Food and Drug Administration (FDA) has published a final rule on “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations,” which permits an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of human subjects.

Jun 7, 2023 | lexology.com | Scott Loughlin |Marcy Wilder |Melissa Bianchi |Melissa Levine

Click here to watch the videoUse of health data in connection with U.S. marketing activities is complex. While regulation on the use of health data for marketing is not new, lawmakers, regulators, and law enforcement have increasingly focused on how companies are using sensitive data for advertising and marketing.