FDA is announcing the expansion of FDA CDER NextGen to include a Drug Supply Chain Security Act (DSCSA) portal. The DSCSA portal enables the agency and trading partners to communicate when the FDA requests information related to investigations of suspect or illegitimate products or during a recall.
The DSCA portal is used to:
Confirm basic information and points of contact for trading partners Notify trading partners when they have messages from FDA Enable trading partners to respond to FDA messages and upload documents DSCSA, enacted in November 2013, gives FDA more regulatory tools to detect and remove dangerous drugs from the supply chain. FDA will ask trading partners to use the DSCSA portal when the agency is investigating suspect or illegitimate products or during a recall, and trading partners will be notified via email when they have a message in the portal.
Read more in the FDA Voices article FDA Protects Patients from Harmful Drugs Through the Drug Supply Chain Security Act to learn how FDA, industry members and other stakeholders have collaborated to implement the requirements over the past 10 years and about highlights of future initiatives.
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