In this second installment of our nine-part deep-dive into the U.S. Food & Drug Administration (“FDA” or “the Agency”) final rule on Laboratory Developed Tests (“LDTs”) – which established a staged plan that will phase out the Agency’s previous policy of enforcement discretion for LDTs – we are taking a closer look at the response to the rule, not only from laboratories and other industry stakeholders but also from members of the legislature. The long and short of it is – people are not happy!Continue Reading LDT Final Rule Series: Part 2 – Response to the Rule

On May 21, 2024, the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) published a warning letter issued to Akan Biosciences, Inc. (Akan) for unresolved inspection observations following a back-and-forth between FDA and Akan. The Form FDA-483 highlights a number of observations about 585 vials of an Akan product, but the warning letter spends considerable time beforehand covering reasons why Akan’s product does not meet the requirements of 21 C.F.R. § 1271.10(a), which qualify certain human cells, tissues, or cellular or tissue-based products (HCT/Ps) for exemptions from key FDCA requirements, including premarket review. Akan’s product is an adipose derived, stromal vascular fraction (SVF) cellular product for allogenic use with the brand name Ayama™.Continue Reading FDA Gets Technical on HCT/P Rules in Warning Letter to Human Tissue Company

Yesterday, the Food & Drug Administration (“FDA” or “the Agency”) issued a highly anticipated – and highly controversial – final rule, which rolls out a four-year, five-stage plan that will phase out the Agency’s previous policy of enforcement discretion for Laboratory-Developed Tests (“LDTs”). The final rule was issued at an astonishing speed compared to FDA’s usual rulemaking timeline,[1] coming not even six months after FDA issued the proposed rule.Continue Reading LDT Final Rule Series: Part 1 – Rule Overview

Earlier this month, the U.S. Food and Drug Administration (“FDA”) issued a draft guidance, “Key Information and Facilitating Understanding in Informed Consent”, with notable implications for clinical trial sponsors, investigators, and Institutional Review Boards.[i] The guidance provides suggestions on which topics of information should be included in the key information section of an informed consent as well as how information can be presented and formatted in an informed consent to aid prospective subjects’ understanding of a clinical trial.Continue Reading Time to Refresh? FDA Issues Draft Guidance on Key Information and Informed Consent

On January 18, 2024, the Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) issued its first untitled letter of the new year to Novartis Pharmaceuticals Corporation (Novartis) regarding a promotional, direct-to-consumer broadcast advertisement (TV Ad) for KISQALI® (ribociclib) tablets, for oral use, indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with:Continue Reading FDA’s Office of Prescription Drug Promotion Issues Its First Untitled Letter of the Year to Novartis for Misleading Statement Relating to KISQALI®

In one of the last guidances released in 2023, the Federal Food and Drug Administration (FDA) finalized guidance for direct-to-consumer (DTC) prescription drug advertisements, specifically advertisements in television and radio format (CCN Final Rule Guidance). The CCN Final Rule Guidance was released to advise small entities seeking to understand and comply with the standards established in the final rule, “Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format” (CCN Final Rule).Continue Reading FDA Issues Final Rule and Guidance on Direct-To-Consumer Prescription Drug Advertisements

On October 23, 2023, the Food and Drug Administration (“FDA”) published a new draft guidance, titled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products, Questions and Answers (the “2023 Draft Guidance”). The 2023 Draft Guidance is a revision to, and builds upon, FDA’s 2014 draft guidance on the same issue, Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices, which itself was a revision to FDA’s 2009 guidance, Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices. Drug and device manufacturers (“firms”) will note that in the 2023 Draft Guidance, FDA introduces multiple new concepts. Addition of terms such as “SIUU Communications” and “Firm-Generated Presentations” appear to broaden the possibilities for firms’ communications with healthcare providers (“HCPs”) while inclusion of concepts such as “scientifically sound” and “clinically relevant” can be read as imposing certain limitations on what can be included in SIUU Communications. FDA’s inclusion of these new concepts provides both guidance and guardrails for firms to ensure SIUU Communications with HCPs stay in line with FDA regulatory requirements. With the 2023 Draft Guidance, FDA continues to be thoughtful and intentional with its views on communications between firms and HCPs, and demonstrates to industry that the agency will continue to evolve its thinking with the advent of new technologies, advancements in science, medicine, and the delivery of care, and in light of the ever-changing modes and methods of communication.Continue Reading From Good Reprint Practices to SIUU Communications: What Firms Need to Know

Earlier this month, the Food and Drug Administration (“FDA” or “the Agency”) issued a highly anticipated proposed rule outlining the regulatory framework and implementation plan for Laboratory Developed Tests (“LDTs”).[1] The history of LDT regulatory status is long and meandering—and summarized below—but in short, FDA has for a long time exercised enforcement discretion over LDTs.Continue Reading FDA’s Proposed Rule on LDT Regulation and the Debate over Agency Deference

On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the “Guidance”) which adds a piece to the ever-expanding puzzle that is FDA’s regulatory scheme for digital health products. The Guidance clarifies how FDA plans to apply its drug labeling regulations to software products that “supplement, explain, or otherwise textually relate to” the use of a prescription drug. As most of FDA’s recent regulatory activity with respect to medical software regulation has been in the device space, this Guidance represents a concerted focus by the Agency to unify its approach to digital health across all regulated categories (e.g., drugs, biologics, and devices).Continue Reading FDA Clarifies Labeling Expectations for Prescription Drug Use-Related Software