The Drug Supply Chain Security Act (DSCSA) is designed to enhance the safety and traceability of pharmaceutical products. Recent FDA guidance, issued on October 9, 2024, introduced temporary exemptions from certain DSCSA requirements, offering businesses more time to comply. DSCSA Exemptions: What You Need to Know for Compliance is essential for understanding these exemptions’ implications and ensuring companies take the necessary steps to remain on track with compliance efforts.
Yearly Archives: 2024
FDA’s Firm Stance on DSCSA Compliance: No More Delays
The FDA recently emphasized the urgent need for compliance with the Drug Supply Chain Security Act (DSCSA), impacting the pharmaceutical industry significantly. At the 2024 FDLI Annual Conference, Patrizia Cavazzoni, Director of the FDA’s Center for Drug Evaluation and Research (CDER), confirmed that there will be no further extensions to the compliance deadline. This announcement marks a critical step in the FDA’s ongoing efforts to secure the pharmaceutical supply chain.
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