Articles and Blogs

Food and Drug Administration

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

[01/30/25]

Posted on January 30, 2025 in Health Law News

Published by: Hall Render

Before the U.S. Food and Drug Administration (“FDA” or “Agency”) halted communications with the industry after the Presidential Inauguration on January 20, 2025, the Agency issued a final guidance for firms in the medical products industry titled,  “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products:... READ MORE

Tags: ,

Five OPDP Letters in 2024: Trend or Coincidence?

[12/06/24]

Posted on December 6, 2024 in Health Law News

Published by: Hall Render

The Food and Drug Administration’s (“FDA”) Office of Prescription Drug Promotion (“OPDP”) has issued its fifth Untitled Letter of the year, matching last year’s total number of enforcement letters. As a reminder, OPDP issued four Untitled Letters and one Warning Letter in 2023. So far this year, FDA has not issued any Warning Letters.... READ MORE

Tags: , , ,

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

[06/05/24]

Posted on June 5, 2024 in Health Law News

Published by: Hall Render

In April 2024, the Food and Drug Administration (“FDA”) issued a Final Rule amending the definition of in vitro diagnostics products (“IVDs”) found in 21 C.F.R. § 809.3. The Final Rule completely changed the regulatory status of Laboratory Developed Tests (“LDTs”) by adding the following additional language: “including when the manufacturer of these products... READ MORE

Tags: , , ,

Data Monitoring Committees in Clinical Trials: FDA Draft Guidance Released

[05/22/24]

Posted on May 22, 2024 in Health Law News

Published by: Hall Render

Earlier this year, the U.S. Food and Drug Administration (“FDA”) announced the availability of new draft guidance titled “Use of Data Monitoring Committees in Clinical Trials” (“Draft Guidance”). When finalized, the Draft Guidance will supersede the March 2006 guidance titled “Establishment and Operation of Clinical Trial Data Monitoring Committees.” A Data Monitoring Committee (“DMC”)... READ MORE

Tags: , , ,

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

[12/15/23]

Posted on December 15, 2023 in Health Law News

Published by: Hall Render

After a slow start to the year, the Food and Drug Administration’s (“FDA”) Office of Prescription Drug Promotion (“OPDP”) now has a total of five enforcement letters for 2023 (four Untitled Letters and one Warning Letter) with potentially the last two letters of 2023 issued on Halloween. Our summary of the first three letters... READ MORE

Tags: , , , ,

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

[11/30/23]

Posted on November 30, 2023 in Health Law News

Published by: Hall Render

On September 29, 2023, the Food and Drug Administration (“FDA”) announced the issuance of a Notice of Proposed Rulemaking (the “Proposed Rule”) to expand the FDA’s regulatory scope over in vitro diagnostics products (“IVDs”) to specifically address Laboratory Developed Tests (“LDTs”). Traditionally, the FDA exercised enforcement discretion over LDTs, meaning that the FDA has... READ MORE

Tags: , , ,

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

[09/08/23]

Posted on September 8, 2023 in Health Law News

Published by: Hall Render

On June 27, 2023, the Food and Drug Administration (“FDA”) issued its Final Guidance for the presentation of “Quantitative Efficacy and Risk Information” in Direct-to-Consumer (“DTC”) promotional labeling and advertisements for prescription drug and biological products, prescription animal drugs and DTC promotional labeling for over-the-counter animal drugs. The Final Guidance provides recommendations on how... READ MORE

Tags: , , ,

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

[09/06/23]

Posted on September 6, 2023 in Health Law News

Published by: Hall Render

After no enforcement actions for the first six months of 2023, enforcement from the Food and Drug Administration’s (“FDA”) Office of Prescription Drug Promotion (“OPDP”) is heating up with two new letters issued in the month of August. The first was a Warning Letter issued on August 4, 2023, to a pharmaceutical manufacturer for... READ MORE

Tags: , , ,

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

[03/29/23]

Posted on March 29, 2023 in Health Law News

Published by: Hall Render

It is hard to believe that spring is finally here and the Food and Drug Administration’s (“FDA”) Office of Prescription Drug Promotion (“OPDP”) has yet to take any enforcement action in 2023. While this seems unusual, it appears consistent with the OPDP’s seemingly measured approach to enforcement actions in recent years. It may also... READ MORE

Tags: , , , , ,

FDA Issues Prescription Drug Importation Guidance: Recommendations for Certain Importers of Canadian Drugs

[07/29/22]

Posted on July 29, 2022 in Health Law News

Published by: Hall Render

In May 2022, the U.S. Food and Drug Administration (“FDA”) issued guidance (“Guidance”) regarding the “Importation of Prescription Drugs” final rule (the “Final Rule”), which became effective November 30, 2020. The Final Rule aims to reduce the cost of covered products and address shortages without increasing risk to American consumers’ health and safety by... READ MORE

Tags: , ,