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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Data Monitoring Committees in Clinical Trials: FDA Draft Guidance Released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]
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