Articles and Blogs

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

On December 27, 2024, the U.S. Food and Drug Administration (“FDA” or “Agency”) published a final rule updating the criteria for the implied nutrient content claim “healthy” that appears on food packaging. The “healthy” label serves as a quick, consumer-friendly signal on food packaging to help consumers identify foundational foods that support a balanced,... READ MORE

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

In August 2023, the U.S. Food and Drug Administration (“FDA”) issued two compliance policies that outlined its strategy for enforcing the drug distribution security requirements established by the Drug Supply Chain Security Act (“DSCSA”), which were set to take effect on November 27, 2023. To support trading partners in meeting these requirements, FDA implemented... READ MORE

Summer may be ending, but enforcement from the Food and Drug Administration’s (“FDA”) Office of Prescription Drug Promotion (“OPDP”) is just heating up. After months of silence (see here for our discussion of OPDP’s first enforcement letter of 2024 five months ago), OPDP issued back-to-back Untitled Letters in July and August bringing the total... READ MORE

It has been a year since the Federal Trade Commission (“FTC”) revised its Guides Concerning the Use of Endorsements and Testimonials in Advertising (“Endorsement Guides” or “Guides”), which advises businesses, influencers, brand ambassadors and other endorsers on how to ensure that advertising using reviews or endorsements is truthful. The FTC’s Endorsement Guides, found in... READ MORE

In April 2024, the U.S. Food and Drug Administration (“FDA”) issued revised draft guidance, “Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers,” (the “Draft Guidance”) intended to address common questions that arise during the process of developing promotional communications for prescription reference products... READ MORE

In May 2024, the U.S. Food and Drug Administration (“FDA”) issued a Final Guidance titled “Remanufacturing of Medical Devices,” clarifying the definition of “remanufacturing” for reusable medical devices in need of maintenance or repair (“Final Guidance”). According to the FDA, the Final Guidance is designed to help medical device servicers understand when certain device... READ MORE

On June 13, 2024, the Supreme Court of the United States unanimously rejected a challenge to the U.S. Food & Drug Administration (“FDA”) approval and regulation of mifepristone (brand name “Mifeprix”), a drug used in medically induced abortions. In a 9-0 decision delivered by Justice Brett Kavanaugh, the Supreme Court held that the plaintiffs,... READ MORE

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