Based on a very insightful webinar in January, Regulatory Insights: The Future of MedTech and Pharma Under the New Administration, which was presented by a panel of two Nelson Labs experts and two Regulatory Compliance Associates (RCA) experts, RCA has published a thorough recap of the discussion on their website. The topics remain relevant to both of our businesses, industries, and customers. There are two of particular concern to Nelson Labs that we will highlight below.
FDA Workforce Reductions and Product Approval Timelines
FDA review timelines for drugs fall under the Prescription Drug User Fee Act (PDUFA) and the Generic Drug User Fee Amendments (GDUFA), which regulate review periods for New Drug Applications (NDA) and Abbreviated New Drug Applications (ANDA), and are set through 2027. Similarly, medical device approval timelines fall under the Medical Device User Fee Amendments (MDUFA), which regulate review periods for premarket approvals (PMA) and 510(k) clearances, and are also set through 2027. While these timelines are unlikely to change, workforce reductions at the FDA may lead to delays across both drug and medical device reviews. The administration’s focus on automation and AI-driven processes may help counterbalance delays, but adoption of these technologies remains in its early stages. Companies can prepare for possible slowdowns by ensuring their submissions are complete, well-documented, and structured for easy review to avoid costly submission delays.
The Impact of Tariffs and Trade Policies on Supply Chains
The administration has signaled tariff increases on imported raw materials and medical components, which could significantly impact MedTech and pharma supply chains. Many companies source materials from countries where production costs are lower, but new tariffs may force them to reconsider domestic sourcing or alternative suppliers. Companies can qualify alternative suppliers and appropriately assess the impact of any resulting device or drug-product changes with additional testing, documentation, and submissions to regulatory bodies, where appropriate. Companies can mitigate risks associated with potential tariff increases and supply chain disruptions by evaluating their sourcing strategies.
The following topics were also discussed:
- The Push for Deregulation
- Changes in FDA Inspections and Compliance Expectations
- The FDA’s Reduced Public Engagement: Challenges for Industry Collaboration
- Key Takeaways: How Companies Can Prepare
The Nelson Labs Expert Advisory Services team has proven experience with regulatory approvals for many different medical device and pharmaceutical products. The team remains up to date with the trends in the industry, standards committees, and regulatory bodies. If you are looking for guidance on how to best prepare your new product for efficient regulatory approval, reach out to us at [email protected].
