CLINICAL SUPPLY REGULATORY ARTICLES

Law, lawyer, judgment, justice auction and bidding-GettyImages-1620250053 FDA Announces 1-Year “Stabilization” Period For DSCSA Compliance — Don't Mistake It For An Enforcement Delay

On August 30 in a new guidance document, the FDA announced the establishment of a one-year stabilization period with regard to the enhanced security and unit-level electronic traceability requirements of the Drug Supply Chain Security Act (DSCSA) that go into effect on Nov. 27, 2023. The FDA makes it clear that this is not an opportunity to delay implementation; rather, it is an opportunity to refine, improve, and stabilize your systems and processes.

CLINICAL SUPPLY REGULATORY VIDEOS

Achieving supply chain resilience is crucial, and flexible distribution strategies and ready-to-use depot and logistics networks are instrumental in establishing limitless flexibility and expertise capable of identifying possible risks.

Industry experts share insights to help you mitigate supply chain risk and accelerate access to novel cell and gene therapies.

This webinar aims to introduce the main regulatory themes, as well as provide a practical insight into converting regulatory theory to practical steps to enable DtP on global studies. 

Succeed in combination product development by understanding the risk factors that may arise and implementing mitigation strategies that will streamline the device development process.

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