Comments Due by October 30, 2023
On September 19, 2023 FDA released its IT Strategy for FY 2024 – 2027.
In 2009, Axendia completed a research study on what was then called FDA’s e-Transformation Initiatives. The study identified key organizational and technology initiatives the Agency was undertaking to advance ongoing electronic communication and interactions with the companies it regulates.
We interviewed Dr. Armando Oliva, Deputy Director for Bioinformatics at FDA to understand what the future held. Dr. Oliva responded, “I think it’s fair to say that 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 discussion 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“.
Fourteen years later, Dr. Oliva’s assessment is becoming a reality.
“The agency considers the new IT Strategy more than a roadmap: it’s a shared vision that unites the FDA’s IT portfolio and will foster innovation, enhance public health outcomes, and lead the FDA into a new era of scientific and technological advancement,” said Vid Desai, Chief Information Officer at FDA in yesterday’s announcement. Desai added, “We are responding to rapid advancements and changes in demand from FDA’s regulated industries, competing for scarce IT talent, understanding use cases for emerging technologies (such as artificial intelligence (AI)), enabling business process modernization, optimizing investment management, and continuing to break down barriers to data sharing and collaboration, all while protecting the assets, intellectual property, and personal information the public entrusts us with.”
FDA Lists Six Key IT Strategic Goals and Objectives
FDA’s IT Strategy revolves around six key goals:
Strategic Initiative 1 – Create a Shared OneFDA Ecosystem. The objectives listed include enhance communication and collaboration, promote transparency, optimize investments, and strengthen governance.
Strategic Initiative 2 – Strengthen IT Infrastructure. The objectives listed include flexible infrastructure offerings, accelerate cloud adoption, ensure service availability, and implement a Zero Trust approach.
Strategic Initiative 3 – Modernize Enterprise Services and Capabilities. The objectives listed include increase business alignment, scale operations, increase digital maturity, improve customer experience, modernize FDA cybersecurity defenses, and reduce technology debt.
Strategic Initiative 4 – Share Data for Mission Outcomes. The objectives listed include enhance data governance, foster OneFDA data literacy, improve data visibility and accessibility, enable advanced data and analytics, and enhance secure data exchange.
Strategic Initiative 5 – Adopt AI and Mission Driven Innovations. The objectives listed include balance policy and technology value, ensure responsible use of innovations, provide thought leadership, and foster innovation.
Strategic Initiative 6 – Cultivate Talent and Leadership. The objectives listed include instill OneFDA mindset, attract and retain talent, hire and develop resilient leaders, and develop skills for the future of work.
FDA is encouraging stakeholders to submit comments on the strategy by October 30, 2023, to ensure that the Agency considers your comments on this strategy for future iterations of the IT Strategy.
FDA also announced its Digital Transformation Symposium is scheduled for December 4 – 6, 2023 to engage the public on its new agenda. Two days are dedicated to discussions on the agency’s internal IT strategy, including details on its leadership and business objectives, and innovations. The following two days are “Vendor Days” days where FDA will have multiple topics surrounding the agency’s IT contracts.
FDA recognizes technology plays an increasingly pivotal role in food, drug, and medical devices’ safety. The Agency’s strategy emphasizes Artificial Intelligence (AI) and other emerging technologies. FDA aims to adapt to emerging technologies, ensuring continuous safeguarding of the American people.
To discuss how this initiative impacts your organization, contact email@example.com to schedule an Analyst Inquiry.
The opinions and analysis expressed in this Briefing Note reflect the judgment of Axendia at the time of publication and are subject to change without notice. Information contained in this report is current as of publication date. Information cited is not warranted by Axendia but has been obtained through a valid research methodology. This report is not intended to endorse any company or product and should not be attributed as such.