CLINICAL SUPPLY PACKAGING 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 PACKAGING VIDEOS

Clinical supply innovators from across the industry share their experiences and lessons learned as they work to normalize the use of adherence measurement tools and smart medicine packages.

As clinical trials evolve to serve various populations and drug sponsors aim to reach patients around the world, utilizing an end-to-end supply chain solution is vital to ensure safe storage and distribution.

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

Catalent's local team in Japan provides comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, and local and global distribution.

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