Publications by Jemalyn A. Harvey

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Enforcement Marches on: OPDP Issues Third Untitled Letter of 2025 Amid Staffing Shake-Ups

[05/23/25]

The Calm Before the Storm: OPDP Released Two Untitled Letters Before HHS’s Reduction in Force, Now What?

[04/17/25]

FDA Issues Final Guidance on Communications About Unapproved Uses of Medical Products

[01/30/25]

A “Healthier” Future? FDA Updates “Healthy” Labeling Criteria

[01/14/25]

Five OPDP Letters in 2024: Trend or Coincidence?

[12/06/24]

From an Instagram Post to a Television Commercial, OPDP Issues Its Fourth Untitled Letter of 2024

[10/16/24]

Summer Is Heating Up with Two New OPDP Untitled Letters

[08/22/24]

A Year Later—Revisiting FTC’s Updated Endorsement Guides

[07/17/24]

FDA Issues Revised Guidance on the Promotion and Advertising of Biologics

[07/08/24]

New Year, New Letter: OPDP Issues Its First Enforcement Letter of 2024

[02/06/24]

Is Five the Magic Number for OPDP Enforcement Letters in 2023?

[12/15/23]

OIG Issues Highly Anticipated General Compliance Program Guidance

[11/10/23]