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The DSCSA deadline has passed, but serialization success is far from guaranteed. Exception handling, data mismatches, and barcode quality continue to create costly disruptions. In our latest blog, Michael Rowe breaks down the new post-implementation pressure points and what teams must do now to protect product movement.

Thousands of rare diseases affect hundreds of millions of people globally, and hope for treatment is on the rise in the form of cell and gene therapies. At Two Labs, we make it a priority to stay on top of industry trends and opportunities relevant to manufacturers. Discover how the Cell & Gene industry is innovating and what YOU need to know!

FDA audits are no longer on the horizon—they’re here. Even small gaps in documentation, incomplete SOPs, or untested processes can lead to a Form 483. Take our DSCSA Readiness Survey to see if your program can stand up to real-world inspection.

At the 2025 HDA Traceability Conference, industry leaders, regulators, and supply chain experts came together to address the realities of DSCSA enforcement — from the urgency of readiness to the complexity of operational alignment. What stood out most: persistent compliance gaps, barcode and data integrity challenges, the looming NDC-12 transition, and how collaboration will be key to staying inspection-ready. Read the full recap.

The FDA is now issuing Form 483s tied directly to DSCSA violations, and one issue is recurring: SOPs that don’t hold up under inspection. For manufacturers, this marks a turning point. Serialization is in place, but without the right operational processes behind it, compliance breaks down, and regulators are responding. Here’s what’s triggering citations and stopping distribution in its tracks: > SOPs that haven’t been updated to reflect final DSCSA requirements > Processes that look good on paper but fail when tested in real-world conditions > Teams that don’t know how to identify, escalate, or act on suspect product > State boards require SOP validation before granting licensure, and say no when it’s missing This isn’t theoretical. Form 483s are already public, and distribution holds and license delays are happening. Two Labs is helping clients get ahead by auditing SOPs, training cross-functional teams, and pressure-testing processes before inspections reveal the gaps.

Small and mid-sized pharma manufacturers are leading the charge in rare disease innovation, but are their patient services programs keeping pace? In our latest white paper with Clarivate, we dive into: > What sets best-in-class PSPs apart > How financial assistance is just the beginning > Why tailored education, adherence tools, and tech-driven insurance navigation matter more than ever > and more! Backed by years of data presented at Asembia, this report is a must-read for teams launching or optimizing PSPs in oncology, neurology, and rare disease markets.