FDA in Flux — October 2026 Newsletter

Welcome to FDA in Flux — A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies.

First FDA Warning Letter Objecting to Compounded “Copies” of Approved Drug Products Signals Enhanced Scrutiny and Potential Enforcement Sweep

What is happening: On the heels of late August 2026 rulings from the Fifth Circuit US Court of Appeals that upheld FDA’s actions to wind down the national drug shortages for injectable tirzepatide and semaglutide drug products (as discussed in our September issue), the agency has issued the first warning letter to a compounding pharmacy alleging that the pharmacy violated the legal prohibition on compounding what is “essentially a copy” of an FDA-approved, commercially available drug. 

The warning letter, dated September 18, 2026, refers to evidence collected during a November 2025 FDA inspection and makes allegations related to drug product adulteration. However, the cited “copy” violations are the most significant development for compounding pharmacies, telehealth platforms that do business with compounders, and financial backers of business operations that rely on such entities. As we explained in June 2025 after the agency originally ended the tirzepatide and semaglutide drug shortages, when a patient needs a compounded version of an FDA-approved drug, the prescriber must document the clinical difference that the changes will provide for that patient in the written order.

FDA points to the following factual findings to conclude that the pharmacy was engaged in compounding “essentially copies” of commercially available drug products: 

• some orders lacked “any prescriber determination” of a significant difference from the commercial product; 
• orders that did have such prescriber determinations used “verbatim” language “suggesting that they may be pre-generated for selection ... rather than written by the prescriber for an identified individual patient”; and
• the large volume of such compounded product orders “suggests that [the] differences ... are pretextual.” 

Why it matters: The evidence and business practices cited in the warning letter as undermining the “copies” exemptions in the Food, Drug, and Cosmetic Act (FD&C Act) are unlikely to be limited to this single compounding pharmacy. The letter may therefore represent the beginning of an enforcement sweep rather than an isolated incident. 

To make its position clear, FDA’s Office of Compounding Quality and Compliance included this strongly worded statement: “Generating prescriptions through means that undermine the individualized nature of a prescriber’s clinical judgment (for example through third-party technology platforms that provide prescribers with pre-selected menu options for choosing a statement of significant difference) call the individualized nature of those determinations into question, potentially undermining claims that such prescriber determinations of significant difference are sufficient to meet the conditions of section 503A.” 

Such operational practices may be common throughout the modern consumer-directed, digitally enabled health care marketplace, which has exploded in the post-pandemic era. Accordingly, this milestone FDA warning letter should lead other compounding pharmacies and their partners and investors to re-evaluate relevant business models and comprehensively reassess legal and regulatory risks to determine if any changes may be necessary. 

FDA Seeks Public Input on Ibogaine Trial Design, Pushing Forward Next Phase of Psychedelic Framework

What is happening: As part of FDA’s broader efforts to establish a regulatory framework to advance psychedelic drug development (discussed in our August 2026 newsletter), the agency is now turning its attention to the unique clinical development considerations associated with ibogaine, a potent psychoactive alkaloid compound with known cardiac risks. On October 5, 2026, FDA issued a Request for Information (RFI) seeking stakeholder input on the design of early phase ibogaine clinical trials, including dose selection, safety monitoring, patient eligibility, treatment settings, and independent ethical oversight. 

The RFI outlines FDA’s “preliminary thinking on a design for an initial, open-label trial in which small groups of participants each receive a single dose of ibogaine, with the dose increasing from one group to the next,” and then requests “comments, data, and information” in response to that thinking. FDA also highlights significant safety concerns associated with ibogaine, including QT prolongation, potentially fatal arrhythmias, and neurotoxicity, while acknowledging important gaps in the existing clinical evidence due to the dearth of relevant research. FDA’s notice emphasizes that it has not reached any final conclusions, invites public comment “on every element” of its proposed open-label trial design, and encourages sponsors of investigational ibogaine drug products to engage directly with the agency on other proposed clinical trial designs through the investigational new drug application (IND) and pre-IND processes.

This initiative aligns with the Trump administration’s broader effort to accelerate research into psychedelic therapies and comes as federally supported research programs led by other Health and Human Services agencies prepare to study ibogaine in patients with opioid use disorder (OUD) and post-traumatic stress disorder (PTSD). The agency also noted in its October 5 announcement that an early-stage clinical study of noribogaine, an ibogaine derivative, as a potential treatment for OUD, had previously been cleared to proceed under an IND.

Why it matters: The agency’s July 2026 final guidance established a broad framework for psychedelic drug development, as did a public hearing hosted by FDA on September 14 that solicited and received wide-ranging perspectives on the potential future therapeutic use of drug products containing psychedelic substances, without focusing on specific products. This month’s notice and RFI specific to ibogaine shows FDA shifting toward addressing the unique scientific, ethical, and safety considerations associated with individual compounds. 

More broadly, the RFI suggests FDA may increasingly supplement its general psychedelic drug development guidance with compound-specific clinical and informed consent expectations for drug products that present unique safety challenges. For ibogaine, noribogaine, and related neuropsychiatric drug product developers, this suggests potentially more complex benefit-risk assessments and safety oversight rules than for many traditional therapeutics. If successfully developed and approved, such higher-risk products can be expected to have even tighter post-marketing controls than currently exist for an esketamine drug product, which represents one of the few psychedelic drugs to be recently approved for outpatient clinical administration. 

Sponsors, medical professionals, patient advocacy groups, investment firms, and any other stakeholders with an interest in the ongoing development and future viability of prescription drug development using psychedelic and psychoactive drug substances should consider sharing their views and any relevant information with FDA. Comments should be submitted by November 20, 2026 (Docket No. FDA-2026-N-10429).

New “Transparency Roadmap” Accelerates FDA’s Changing Public Disclosure Policies

What is happening: FDA Acting Chief of Staff, Deputy Commissioner for Strategic Initiatives, and Special Counsel Lowell Zeta published an official FDA Voices blog post on October 2, 2026 entitled “Transparency Makes Modern Regulatory Science Stronger — FDA’s Transparency Roadmap.” The blog post focuses on planned, upcoming initiatives to enhance the agency’s external release of information, following the significant September 2025 decision to begin releasing redacted Complete Response Letters (CRLs) for unapproved drug and biological products soon after CRL issuance. 

The Transparency Roadmap discusses the purported benefits of this recent “CRL disclosure initiative” and highlights the following upcoming agency goals:

• Initiating rulemaking that would allow the agency to disclose that a human drug or biological product marketing application has been submitted for review. 
• Encouraging sponsors to publicize whenever an IND is submitted to FDA (which the agency notes occurs today for “about 96% of novel drug or biologic filings”) and working to increase compliance with mandatory ClinicalTrials.gov reporting requirements. 
• Increasing the agency’s public release of appropriately redacted clinical study reports and other scientific information about FDA-approved products, as well as redacted inspectional observation reports (Forms FDA 483) and other compliance-related documents. 
• Improving stakeholder accessibility to information about successful uses of new approach methodologies (NAMs) and real-world evidence (RWE) to support marketing submissions. 
• Finalizing a rule to create a new type of patient labeling, called “Patient Medication Information,” aimed at simplifying and standardizing the information patients receive for outpatient drugs and blood products. 

In particular, Zeta references the recently signed information-sharing agreement with the US Securities and Exchange Commission (SEC) as being key to “reinforc[ing] the FDA’s transparency commitments by ensuring that companies cannot selectively communicate FDA regulatory developments to markets — and that when they do communicate, they do so accurately and completely.” We discussed this new FDA-SEC agreement in our September 2026 newsletter. 

Who may be affected: Changes in FDA’s policies related to the proactive release of documents previously considered confidential — such as CRLs, Forms FDA 483, or clinical study reports — directly impact the sponsors who are the subjects of those documents, while also providing useful information to other parties, from competitors and business partners, to patients and plaintiff-side attorneys. Accordingly, procedural due process matters with respect to such documents, and sponsors may be willing to challenge the agency’s actions, as in the context of the September 2025 “real-time” CRL disclosure decision that prompted a citizen petition demanding FDA improve its procedures for such external disclosures (as discussed in our May 2026 newsletter). 

Outside of sponsors’ interest in protecting confidential and proprietary information, the agency’s Transparency Roadmap, if implemented as envisioned, has the potential to clarify regulatory requirements and accelerate new product development by making resources more easily accessible to all stakeholders. Such improvements would not only benefit the medical product industries and their supporters, but also health care providers, patients, and caregivers that continue to demand that treatments, diagnostics, and clinical tools get to market more quickly. 

While FDA Ponders the Correct Approach, the Health Care Industry Charges Ahead with Clinical AI Products

What is happening: Development and deployment of AI models in the health care industry is rapidly moving beyond simple tools intended to assist with administrative tasks to more advanced agentic systems with a certain degree of autonomy. The speed at which the health care industry has adopted AI has left FDA struggling with how to oversee these new innovations and how to enforce its regulations. Although FDA is always in a position of reacting to new technologies as they arise and historically has been slow to propose new regulations or guidance, multiple factors have converged to make it even more difficult for the agency to regulate AI-enabled devices in the current moment:

• The FD&C Act and FDA’s medical device regulations were not designed for software devices and are not a good fit for the regulation of AI-enabled devices or the non-traditional entities that are developing such devices.
• The incredible speed of AI innovation and of changes within models from machine learning requires FDA to adopt new approaches to ensure proper review for safety and effectiveness when such devices are submitted for marketing authorization.
• Health care institutions are developing their own in-house, AI-enabled tools to assist doctors with diagnosis, treatment planning, and other clinical uses; these non-commercial tools are not being submitted to FDA for review due to an interpretation of regulatory exemptions purportedly allowing such entities to develop and use such tools solely in-house and on their own patients.

FDA has implemented certain additional review processes, such as the predetermined change control plan (PCCP), for AI-enabled devices and accrued resources specifically for digital health products (e.g., the Digital Health Center of Excellence). However, researchers have found that the current regulatory framework has not worked especially well to assure the safety and effectiveness of AI-enabled devices (for example, see this recent article published on JAMA Network Open). 

More recently, FDA’s discussion paper “Considerations for the Regulation of Generative AI-Enabled Medical Devices” (see our previous newsletter) merely shows how far behind FDA is in developing an adequate approach to one type of AI, while industry simultaneously plows ahead with medical uses for more advanced agentic AI.

Why it matters: FDA is the agency charged with ensuring the safety and effectiveness of medical devices, but it cannot do so effectively without a regulatory framework that is fit for the purpose of regulating software and AI. Investors in AI-enabled technologies for health care uses (or even purported wellness uses) should look for specific information from developers about FDA regulatory compliance — and beyond that, how the developers plan to monitor and respond to emerging risks or new state-level regulatory requirements. Even though federal and state laws have not caught up to AI with respect to controlling potential and actual risks, developers in the health care space must consider the need for such controls and implement them for the inevitable situation where a patient or user is harmed.

Furthermore, cutting-edge uses of AI in health care are increasingly being developed and deployed within large health systems, with the safety and performance of such technologies governed by in-house AI governance committees. As health care providers use AI-enabled technologies for more patient-specific treatment purposes, patients, caregivers, and health care institution leadership should be alert when such technologies are used (or are proposed for use) and should ask questions about how they were tested and about relevant safeguards. In addition, if an institution decides to commercialize its in-house, AI-enabled device software outside its walls, or if FDA determines the current regulatory exemptions are inapplicable, the institution will need to comply with FDA requirements — such as obtaining marketing authorization, registration and listing, and implementing a quality management system — which can be onerous and expensive.

Laws and regulations won’t stop the coming wave of advanced AI-enabled technologies for clinical applications. And although FDA can take some actions, likely needing assistance from Congress, to develop regulations and guidance that can help developers and deployers and mitigate certain risks to patients, all health care industry stakeholders need to remain aware of potential risks and advocate for appropriate governance processes. For example, the American Medical Association recently released a “governance framework for agentic AI assuming clinical functions” that can serve as a starting point for institution-specific discussions on this critically important topic. 

FDA Issues Robotic Surgical Device Draft Guidance and Announces Autonomous and Remote Teleoperation Robotics Workshop

What is happening: FDA’s Center for Devices and Radiological Health (CDRH) recently issued draft guidance providing recommendations for developers on nonclinical testing, clinical data, and labeling to support premarket submissions for certain robotically assisted surgical devices (RASDs) operated by or under the supervision of a clinician. FDA describes RASDs as teleoperated, software-controlled systems that help qualified practitioners precisely position and control surgical instruments in open, minimally invasive, or endoluminal procedures. These systems use a leader/follower control architecture, and some include automated functions to enhance user capabilities. 

CDRH addresses performance and safety characteristics specific to robotic surgical platforms, including the following, with the goal of promoting consistency and making review of premarket submissions more efficient:

• teleoperation capabilities, system controls, and kinematics and dynamics; 
• visualization and reliability; 
• software, cybersecurity, and wireless technology; 
• human factors and training; and 
• electrical safety and clinical evidence. 

Interested stakeholders should submit any feedback on the draft guidance by November 24, 2026 (Docket No. FDA-2026-N-9505). 

Simultaneously, FDA announced a hybrid public workshop for December 2–3, 2026, titled “Evaluating Benefit-Risk in Robotic Medical Devices with Autonomous or Remote Teleoperation Capabilities.” Workshop discussions will focus on terminology, technical considerations, and the probable benefits and risks of these technologies. CDRH indicates that feedback from the workshop may inform future policy and encourages developers of novel robotic medical devices to engage with the agency early. 

Why it matters: Together, these announcements indicate that FDA is preparing for the next generation of robotic devices on two fronts. The premarket submissions guidance would set clearer expectations for supervised, teleoperated surgical systems, while the workshop starts a policy discussion on autonomous and remote-operation capabilities that the September 2026 draft guidance does not cover. 

Manufacturers should benchmark their current and planned submissions against the draft recommendations and consider submitting comments before the November 24 deadline. Companies developing devices with autonomous or remote teleoperation features should also consider taking part in the December workshop, as it may shape FDA’s approach to these technologies. 

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