At FDA, The Future Is Already Here


“The future is already here- it’s just not evenly distributed,” declared William Gibson.

Axendia published the “FDA’s e-Transformation Initiatives” research report” in 2009. This report, based on interviews with FDA officials, identified key organizational and technology initiatives the Agency was undertaking to advance electronic interactions across the ecosystem.

“I think it’s fair to say that the Agency is actively moving toward an electronic world where all regulated product information comes in electronically. I couldn’t tell when that is going to happen, but certainly, there are active discussions underway to move to an all-electronic submission environment for all FDA-regulated product information, whether it be product quality, manufacturing, pre-market, or post-market data,” stated Dr. Armando Oliva, then Deputy Director for Bioinformatics at FDA.

Fourteen years later, that future is already here – and its distribution leans heavily toward the FDA.

This was evident as Axendia participated in the FDA’s Digital Transformation Symposium hosted by the Office of Digital Transformation at the Agency’s headquarters.

Kudos to Vid Desai, Jess Berrellez, and the #ODT for a great event!

During the symposium, Agency leadership shared their vision, business objectives, innovations, and achievements for digital transformation at FDA.  In addition, representatives from nearly every center and office presented detailed examples of how they are leveraging the latest technologies to achieve their mission. 

FDA’s Holistic Modernization Approach

Vid DesaiFDA CIO, kicked off the Symposium with a keynote sharing “Perspectives on Holistic Modernization.”  He shared the state of the Agency’s digital transformation journey. He emphasized how the Office of Digital Transformation (ODT) is aligning IT initiatives with internal and external stakeholders to accelerate innovation. In addition, Vid provided valuable insights into the FDA’s Information Technology (IT) Strategy, and its modernization framework.

To support a systematic and holistic modernization approach, the Agency is following its MAPs (Modernization Action Plans)

In addition, Jessica Berrellez, Executive Officer at ODT,  and Joseph Montgomery, Director, Office of Enterprise Portfolio Management and Office of Information Management and Technology at ODT,  revealed the road ahead by providing a preview of the FDA’s IT Operating Plan.

The plan is based on an Agency-wide IT portfolio assessment and aims to align investment with strategic goals.  To this end, the FDA is leveraging a Technology Business Management (TBM) model to accelerate digital transformation while optimizing cost.   

Shaping the OneFDA Future

ODT intends to harness the power of information to drive informed decisions and steer FDA towards sustainable success in an ever-evolving digital landscape by:

  • Transforming IT Governance:
    • Supporting and an end-to-end governance model that improves decision-making, risk management, and efficiency.
  • Executing to the IT Strategy and Operating Plan
    • Complementing the IT Strategy, the IT Operating Plan offers tactical guidance for governance and execution.
  • Implementing its Data and Technology Management Strategy
    • Driving strong alignment between tech initiatives and Agency goals to enhance efficiency and business outcomes.
  • Creating a TBM Center of Excellence
    • Promoting TBM framework adoption and centralizing portfolio data.

FDA’s Modernization Framework is the cornerstone of the Agency’s strategy, focusing on technology, data, cybersecurity, enterprise transformation, and leadership.

A Shared Vision for Excellence

The IT operating plan is more than a roadmap; it is a shared FDA vision for excellence. This unified approach will innovate and enhance public health outcomes. With technology playing a pivotal role in food, drug, and medical devices’ safety, the strategy emphasizes Artificial Intelligence (AI) and other emerging technologies.

FDA aims to be agile and forward-thinking in the adoption of emerging technologies to achieve the following goals:

  • Create a Shared OneFDA Ecosystem
    • Objectives include enhancing communication and collaboration, providing flexible offerings, and increasing business agility.
  • Strengthen IT Infrastructure
    • Objectives include improving security and privacy, modernizing infrastructure, and enhancing data visibility.
  • Modernize Enterprise Services and Capabilities
    • Objectives include providing modern tools and services, increasing automation, and improving user experience.
  • Share Data for Mission Outcomes
    • Objectives include enhancing data quality and accessibility and improving data sharing and interoperability.
  •  Adopt Mission-Driven Innovations
    • Objectives include balancing policy and innovation, fostering continuous improvement, and promoting innovation.
  •  Cultivate Leadership and Talent
    • Objectives include developing a culture of innovation, promoting diversity and inclusion, and fostering leadership and talent.

It was refreshing to see FDA driving transformation from the top-down and the bottom-up, to create a OneFDA ecosystem that leverages modern technologies across centers, functions, and the medical product life cycle to improve patient outcomes.

One example is the Inspection Modernization initiative.  Its goal is to develop a single end-to-end Enterprise Inspection Platform. This single Agency-wide repository and workflow system would drive standardization of the inspection process and accelerate review and decision-making across the Agency.

Embedding AI in Everything

“FDA is not building a center of excellence on AI. AI will be embedded in everything we do” said Mohammed Sohail Chaudhry, ODT’s Chief Technology Officer.  This assertion was supported by Ram Iyer, ODT’s Chief Data Officer.  Ram confirmed the Agency’s focus on scaling programs that improve connectivity to create AI-ready data.  To this end, FDA is mastering its data via Enterprise Data Management and providing platforms and services that encourage AI innovation.

Day 2 of the Symposium was full of presentations highlighting the use of AI and ML across the Agency to:

  • Protect public health
  • Improve outcomes with limited resources
  • Identify emerging trends sooner
  • Facilitate trade
  • Complement and codify human intelligence
  • Move towards “smart” regulation

In Brief

At FDA, the future is here.  This was evident as FDA leadership shared their vision, business objectives, innovations, and achievements at the Digital Transformation Symposium

In addition, representatives from nearly every center and office presented detailed examples of how they are leveraging the latest technologies to achieve their mission.

Unfortunately, many in Industry are still operating in the past, asking questions like:

  • Will the FDA accept cloud solutions?
  • When will FDA tell me how to validate AI applications?
  • When will the CSA Guidance be finalized?

As the Agency looks ahead, OTD leadership is confident that its framework will optimize mission delivery for FDA’s centers and offices.

FDA is adopting emerging technologies like Gen AI and Quantum computing; and implementing tomorrow’s technology today!

It’s time for our industry to even the distribution of the future that is already here…

To discuss how this initiative impacts your organization, click on this link to schedule an Analyst Inquiry on this topic.

The opinions and analysis expressed in this post reflect the judgment of Axendia at the time of publication and are subject to change without notice. Information contained in this post is current as of publication date. Information cited is not warranted by Axendia but has been obtained through a valid research methodology. This post is not intended to endorse any company or product and should not be attributed as such.

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