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Enforcement DSCSA

Gardner Law

FDA’s Center for Drug Evaluation and Research (CDER) Issues FY2023 Annual Report

Gardner Law on

In January 2024, the Office of Compliance at the FDA’s Center for Drug Evaluation Research (CDER) released its Annual Report for FY2023. The Annual Report contains several useful pieces of information for drug companies and...more

McDermott Will & Emery

FDA Announces Delay in Enforcing DSCSA Requirements for Dispensers

On June 30, 2015, the U.S. Food and Drug Administration (FDA) announced its intention to exercise its enforcement discretion to delay until November 1, 2015, its enforcement of drug product “track and trace” requirements...more

King & Spalding

FDA Announced a Four-Month Enforcement Delay on Certain Drug Supply Chain Security Act Product Tracing Requirements for Dispensers

King & Spalding on

FDA Does Not Intend to Enforce Product Tracing Requirements Related to Dispensers’ Receipt and Maintenance of Product Tracing Information Until November 1, 2015. It Did Not Delay Dispenser Requirements With Respect to Product...more

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