Articles and Blogs

In April 2024, the U.S. Food and Drug Administration (“FDA”) issued revised draft guidance, “Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers,” (the “Draft Guidance”) intended to address common questions that arise during the process of developing promotional communications for prescription reference products...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

Earlier this year, the U.S. Food and Drug Administration (“FDA”) announced the availability of new draft guidance titled “Use of Data Monitoring Committees in Clinical Trials” (“Draft Guidance”). When finalized, the Draft Guidance will supersede the March 2006 guidance titled “Establishment and Operation of Clinical Trial Data Monitoring Committees.”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

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

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

On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) finalized “Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014. The Final Guidance reflects the FDA’s recommendations on informed consent and the regulatory requirements in place to... READ MORE

In June 2023, the Food and Drug Administration (“FDA”) released Draft Guidance outlining its current view of the psychedelic research landscape. The Draft Guidance is aimed at researchers conducting clinical trials using psychedelic drugs. While the FDA does not define psychedelics, it indicated that the shorthand term “psychedelic” includes “classic psychedelics,” which are typically understood to... READ MORE

On May 2, 2023, in a move intended to accelerate the adoption of digital health technologies, the U.S. Food and Drug Administration (“FDA”) released draft guidance regarding the conduct of decentralized clinical trials (“DCTs”) for drugs, biological products and devices. This draft guidance expands on previous FDA recommendations released in the midst of the... READ MORE