Former Commissioner Makary highlighted the agency’s aim to decrease time to decision on applications and increase efficiency of reviews.
Attorneys from Duane Morris’ Life Sciences and Medical Technologies Industry Group attended the Food & Drug Law Institute’s Annual Conference, which featured participation from senior leadership at the Food and Drug Administration (FDA). Notable attendees included then-Commissioner Martin A. Makary, Chief Counsel Sean Keveney and representatives from FDA’s Center for Drug Evaluation and Research and Center for Devices and Radiological Health (CDRH).
Former Commissioner Makary highlighted the agency’s aim to decrease time to decision on applications and increase efficiency of reviews. He also discussed the trend of research and manufacturing moving internationally and potential reforms to make domestic manufacturing and research more feasible.
Dr. Makary highlighted several new FDA developments intended to address agency goals, including:
FDA’s One-Day Inspection Pilot
As part of this pilot, FDA will use artificial intelligence to identify low-risk facilities and conduct targeted screenings. The former Commissioner noted that this pilot will allow the agency to conduct a greater number of inspections.
Streamlining the IND Process
Dr. Makary discussed concerns with the speed of Institutional Review Boards, the need for more master contracts with hospitals, and the potential for minimizing and clarifying investigational new drug (IND) requirements through guidance or rulemaking. He noted that companies are including excessive documentation in INDs and that the agency plans to clarify what is actually required in IND applications. He also explained that minimizing IND requirements to focus on safety, particularly safety in Phase 1 trials, and deferring issues that may implicate later trial phases would decrease the pre-IND timeline.
Real-Time Clinical Trials Pilot
FDA announced its initiative to implement real-time clinical trials toward the end of April as part of a broader effort to improve efficiency and accelerate the timeline to regulatory decisions. Dr. Makary discussed this clinical trials pilot as an opportunity for the agency to immediately identify safety signals and reduce “dead time” between Phase 1 trials and a filing such as a Biologics License Application. During this “dead time,” there may be no development progress; the agency views real-time clinical trials as a potential bridge between defined phases for “continuous” trials.
Making Complete Response Letters Public
Dr. Makary discussed how publishing Complete Response Letters will provide sponsors with greater insight into the agency’s decision-making process.
Psychedelics
Dr. Makary made no promises regarding the outcome of FDA’s consideration of drug approvals for psychedelics but addressed the agency’s goal to render timely decisions on its reviews. He explained that even if the exact mechanism is not known for psychedelics, this does not indicate that a whole class of potential drugs should be disregarded.
Quality Management System Regulation (QMSR)
A highlight of the two-day conference was the new QMSR, which came into effect in February 2026. QMSR harmonizes medical device current Good Manufacturing Practices (cGMPs) requirements with those of other regulatory agencies by incorporating by reference ISO 13485 (2016). FDA’s Chief Counsel and representatives from CDRH discussed the “risk-management” focus of QMSR and highlighted the new inspection process reflected in the updated Inspection of Medical Device Manufacturers Compliance Program: 7382.850. CDRH representative Keisha R. Thomas discussed that the foundation of the transition away from Quality System Inspection Technique (QSIT)-based inspections is that risk assessment is central to the total product life cycle. Thomas encouraged manufacturers to read the preamble to the final QMSR rule, which clarifies the revisions to the regulatory framework and provides insight into FDA’s reasoning.
CDHR has conducted inspections under the new framework, and highlighted 483 Observation trends, including:
- Clause 7.1 (Planning of Product Realization): failures to risk management processes or missing required elements in product realization planning
- Clause 7.4.1 (Outsourcing/Purchasing): lack of documented procedures for supplier selection and monitoring, or failure to maintain records of supplier evaluations
- Clause 8.2.2 (Complaint Handling): missing justifications for not investigating complaints and inadequate documentation of complaint-handling procedures.
Additionally, FDA expressed that contract manufacturing organizations (CMOs) and similar contract entities must ensure they understand their role in QMSR compliance with respect to the activities they conduct on behalf of original equipment manufacturers (OEMs). Both OEMs and CMOs should be conducting internal audits.
Industry Perspectives on QMSR Compliance
An industry representative provided valuable insight that, although they fully expect inspectors to be trained under the new model when inspecting facilities, they have prepared their staff to respond to inquiries under both the former QSIT framework and the new QMSR framework in case there is a delay in inspector adaptation to the new process. Of note, industry members expressed concern regarding smaller, more domestic manufacturers and the potential for disproportionate difficulty with compliance as compared to larger, international companies. Industry members and FDA discussed the resources available to such entities who may need to interface with FDA for clarity on regulatory changes—with FDA suggesting contacting the Division of Industry and Consumer Education.
FDA’s Use of Artificial Intelligence
Attendees regularly asked the agency for information about its use of artificial intelligence. Broadly, representatives made clear that the agency uses AI internally to minimize administrative burden. For example, the agency may use AI when reviewing an application to locate past reviews and connect data from the Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research, which is housed separately. CDRH representatives explained that CDRH uses AI to sort through information to support FDA personnel when they draft deficiency letters. However, it was made clear that AI will not be used for primary drafting, for example, to draft inspection observations.
Conclusion
Overall, the agency appears to be focused on improving the efficiency of application decision-rendering, the clarity of its guidance and the availability of innovative products, which in turn, will support domestic drug and device manufacturing and development.
For More Information
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