FDA Reaffirms Commitment to Technology With Technology Modernization Action Plan

Rapid advances in technology have led the Food and Drug Administration to create the Technology Modernization Action Plan (TMAP). If your company isn’t familiar with the FDA’s approach to technology, you may need additional pharmaceutical and medical device training.

The FDA has made it clear that advances in “genomic sequencing to development of cell and gene therapies and nanotechnologies” have the potential to improve the lives of “millions of Americans.”

Our reliance on technology requires solutions that are compliant, safe, and that guarantee quality through every step of the supply chain.

“FDA is committed to pursuing its Technology Modernization Action Plan as a fundamental near-term step. Subsequent actions will focus on data and application of solutions unlocked by the TMAP,” wrote the agency in their official release of TMAP.

Are you familiar with the TMAP, and how it may impact this industry as a whole?

What Does TMAP State?

1. Fundamental Change Is Needed at the FDA

Technology is revolutionizing the healthcare industry. The FDA acknowledges that technology is rapidly evolving, and with that change, new therapies, prescriptions, and treatments are improving and developing. 

But technological advancement comes with new forms of data and the capabilities to analyze and disseminate this data. The FDA plans to modernize its technical infrastructure, which will require the adoption of new hardware, software, technologies, and strategies. 

The FDA understands that technological advancement will require the agency to improve its ability to scale to provide effective regulatory oversight.

Your company may require additional pharmaceutical training to prepare and implement systems that are compliant with the FDA’s new policies and actions.

2. Technology Is the Answer

The only way to keep pace with technological advancement is through the use of technology itself. The FDA knows this and is pursuing a rapid modernization plan.

Their plan will include:

• Building a strong foundation that’s rooted in dynamic, enterprise-wide collaboration among Agency programs. The agency plans to integrate a cloud strategy, improve software development capabilities for B2B needs, data integrity, leveraging “as-a-service” platforms, multi-year technical planning, IT governance, and through “retiring legacy systems and software.”
   
• Developing technology that will allow the agency to pursue a regulatory use case strategy. The agency plans to develop tools that will establish industry use cases that serve as foundational benchmarks for regulatory issues. They plan to accomplish this by creating the agency’s product development capabilities, creating short and long-term use cases and collaborating as necessary to achieve scale. The agency believes its modernization policy will require direct engagement with public stakeholders.
   
• Improving communications with both public and private industries. The FDA acknowledges that they must maintain an open dialogue with public and private entities in the healthcare industry. They see this as the only path to creating a transparent “exchange of ideas” with healthcare providers, innovators, and technology companies.

3. A Transparent and Accountable Approach Is Necessary

Communication is an essential aspect of any regulatory process. Parties must have effective lines of communication that make it possible to discuss regulatory affairs, oversights, and corrective action.

The FDA plans to implement a strategy that prioritizes:

• Stakeholder engagement
• Frequent updates
• The creation of tools to enhance public transparency.
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Keep Your Industry Training Up to Date

The Center for Professional Innovation and Education offers pharmaceutical & medical device training that your organization can use to stay up to date on the latest FDA developments. It’s clear that the FDA is betting big on technology, so take the time to update your internal policies and to provide your staff with the training they need.

Here are a few courses related to technology that you may find valuable:

• Advanced Blockchain Concepts for the Pharmaceutical and Medical Device Industries
• Overview of FDA Regulatory Compliance for Medical Devices
• Computer System Validation
• FDA Inspections - What Regulators Expect and How to Prepare

Are you interested in learning more about how technology will impact your industry? Get in touch with a CfPIE member today by calling 1-610-648-7550 or email us at [email protected].