Unit-level serialization under DSCSA enhances drug tracking, enabling precise recalls and improved supply chain visibility. Compliance without integrated workflows limits serialization benefits; ...
In a recent public meeting, FDA and pharma industry officials met to discuss the standards and architecture required for companies to successfully comply with the Drug Supply Chain Security Act. As ...
U.S. drug manufacturers with products in late-stage clinical trials and on the path to FDA approval may be overlooking an important consideration: preparing for serialization. Starting this November, ...
November 2023 U.S. Drug Supply Chain Security Act (DSCSA) now in effect; Tecsys WMS provides regulatory adherence and optimized healthcare distribution efficiency. MONTREAL, Nov. 27, 2023 /PRNewswire/ ...
As the U.S. pharmaceutical industry breathes a collective sigh of relief, Adents, provider of versatile and easily deployable serialization and track-and-trace software solutions, is urging pharma ...
Manufacturers must begin to comply with the Drug Supply Chain Security Act (DSCSA) serialization and verification requirements on November 27, 2017 (Compliance Date ...
The major markets for pharmaceuticals have been forever transformed with the arrival of mandated serialization. With both the United States Drug Supply Chain Security Act (DSCSA) and European Union ...
The U.S. Food and Drug Administration (FDA) recently published a guidance for immediate implementation, Enhanced Drug Distribution Security Requirements Under Section 582(g)(1), that provides a ...
During the last quarter of this year, pharmaceutical manufacturer Cetylite Industries Inc. plans to test the application process of serialized numbers on its packaged drug products, with the intention ...
November 2023 U.S. Drug Supply Chain Security Act (DSCSA) now in effect; Tecsys WMS provides regulatory adherence and optimized healthcare distribution efficiency. Tecsys' Elite WMS for Healthcare ...