How to Navigate FDA’s New Priorities

Recently the United States Commissioner of Food and Drugs, Martin Makary, MD. MPH, and the Director of the Center for Biologics Evaluation and Research (CBER), Vinay Prasad, MD. MPH, published a joint article outlining new priorities for the FDA¹. Among these new priorities, three have significant impact on pharmaceutical companies and biotechs with candidates in the pre-clinical and clinical phases: 

1. Accelerating Cures
2. Unleashing AI
3. Harnessing Big Data 

The intent of all three of these priorities is to get life saving and life improving therapies to patients faster, but they will require firms in the industry to change their ways of working. Let’s take a look at each in turn. 

Accelerating Cures 

FDA will start a pilot program for acceleration that will require sponsors to “submit much of the arduous paperwork to FDA in advance of their final application.”¹ This includes elements such as manufacturing plans, draft labels, and packaging prior to the completion of a clinical trial. This means companies can no longer work on these elements in sequence, but must start developing their plans in parallel. It increases the criticality of developing fit-for-purpose Quality Management Systems that can quickly scale to GMP readiness, as approval timelines are targeted to be much faster. Also, for companies with virtual or hybrid models, this means robust vendor oversight and governance must be fully developed as early as possible. 

At the same time, the authors have committed the FDA to becoming more “user-friendly…partner[ing] with industry rather than tak[ing] a receive-only posture,”¹ and “provid[ing] [small companies] the regulatory navigation that companies may lack internally.”¹ This will certainly help biotechs navigate the new pilot programs, but they can gain an even greater advantage by seeking out guidance from experienced industry experts to assess their Quality and Vendor Oversight processes to remediate any gaps and implement these capabilities earlier in the development lifecycle. 

Unleashing AI 

The FDA has completed its first-ever AI-Assisted Scientific review pilot and is looking to implement the practice agency-wide.² The intention is to speed the first-pass review process of submissions and aid in generating standardized tables. What this means for companies is that the data in their submissions must be well structured and fully traceable. As a result, internal data management and integrity practices become even more important. Digitization of data capture, analysis, and transfer via validated methods is paramount in ensuring high data quality and right first time review. Making the transition from paper notebooks and records can be challenging for small companies, but solutions for making this happen have proliferated, and with the right guidance on implementation and validation, the investment can pay huge returns.   

Harnessing Big Data 

The authors envision Big Data allowing “a broad move from a requirement for 2 pivotal clinicals trials used by FDA regulators for many products in the past down to 1.”¹ This is contingent on the availability and robustness of Real World Data (RWD) and Real World Evidence (RWE), as well as the data generated in targeted trials. This again implicates companies ability to capture, aggregate, and analyze data in a way that is integral and traceable. Digitization and well-structured data management practices will again be key. 

In Summary 

Firms looking to align with and take advantage of FDA’s new priorities to accelerate approvals should: 

• Incorporate fit-for-purpose Quality Management Systems at the very beginning of the development cycle, or, if already in development, seek expert guidance to assess and remediate those systems so they can scale quickly to GMP readiness 

• Enhance their Vendor Agreements and Oversight processes to ensure data visibility and robust Quality Management Systems
•  
• Digitize to the extent possible their data capture, aggregation, and analysis processes and ensure a robust Data Management program is in place from the earliest possible point. 

Mike Shafer, Managing Director, Quality & Compliance

Mike is a seasoned executive in life sciences, focused on risk-based Quality Management. He is passionate about helping clients scale quality as a competitive advantage. Mike brings deep Quality & Compliance expertise to TriRadial, including:

• Quality Assessments
• QMS Design and Remediation
• Phase-appropriate Quality Management and risk-based compliance
• Quality Process Transformation and SOP Optimization
• Computer Systems Assurance
• Inspection Readiness

References: 

¹ Makary, M. and Prasad, V. (2025, Jun 10). Priorities for a New FDA. JAMA. https://jamanetwork.com/journals/jama/fullarticle/2835314 

² US Food and Drug Administration. (2025 May 08). FDA Announces Completion of First AI-Assisted Scientific Review Pilot and Aggressive Agency-Wide AI Rollout Timeline. FDA. https://www.fda.gov/news-events/press-announcements/fda-announces-completion-first-ai-assisted-scientific-review-pilot-and-aggressive-agency-wide-ai