Publications by Carolina M. Wirth

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Quoted in, “FDA’s Deceptive Drug Ad Focus Leaves Telehealth Sites Guessing,” Bloomberg Law, October 2025.

[10/14/2025]

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

[05/23/25]

Texas District Court Strikes Down FDA’s Laboratory Developed Tests Final Rule Less Than Two Months before Phase I Implementation

[04/28/25]

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]

DSCSA Update – FDA Extends Deadline for Connected Trading Partners to Meet Requirements

[10/18/24]

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]

NAD Recommends that Medical Device Manufacturer Discontinue Advertising Claims Following Competitor Challenge

[07/11/24]

FDA Issues Revised Guidance on the Promotion and Advertising of Biologics

[07/08/24]

Remanufacturing or Servicing of Medical Devices: FDA Issues Final Guidance Providing Additional Clarification

[06/21/24]

U.S. Supreme Court Issues Ruling Rejecting Challenge to Mifepristone Access

[06/18/24]

FDA's Data Monitoring Guidance Reveals Future Expectations

[06/11/2024]

From Discretion to Regulation: What FDA’s Final Rule Means for Laboratory Developed Tests

[06/05/24]

Data Monitoring Committees in Clinical Trials: FDA Draft Guidance Released

[05/22/24]

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]

A Whole New World for Laboratory Developed Tests – FDA Proposes End to Its Longstanding Policy of Enforcement Discretion

[11/30/23]

FDA Finalizes Its Informed Consent Guidance for IRBs, Clinical Investigators and Sponsors

[10/05/23]

FDA Outlines Considerations for Conducting Clinical Investigations Using Psychedelic Drugs

[09/15/23]

FDA Issues Final Guidance on Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertising

[09/08/23]

OPDP 2023 Enforcement Heats Up with Two New Letters Issued in the Month of August

[09/06/23]

Federal Court of Appeals Panel Issues Ruling in Litigation Challenging FDA Approval of Mifepristone

[08/31/23]

The Wait Is Over . . .  OPDP Issues Its First Untitled Letter of 2023 

[07/14/23]

A Look Back at the Office of Prescription Drug Promotion Enforcement in 2022 and Lessons for 2023

[03/29/23]