This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
News|Articles|February 8, 2019
FDA Seeks Participants in DSCSA Pilot Program
Author(s)Pharmaceutical Technology Editors
Supply chain players are eligible to participate in FDA’s pilot program to develop an electronic system for tracking drug products.
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FDA is seeking volunteers from the pharmaceutical distribution supply chain to participate in a pilot program designed to establish pilot projects that will evaluate methods to improve the supply chain safety and security. Elements of the program, as well as procedures for applying by March 11, 2019, were published in the Federal Register on Feb. 8, 2019.
Key issues to be explored include using a product identifier for product tracing, improving technical capabilities of the supply chain, and identifying system attributes needed to implement the requirements established under the Drug Supply Chain Security Act (DSCSA).
The Pilot Project Program Under the DSCSA is intended to assist FDA and supply chain participants in the development of the electronic system-targeted for operation by Nov. 27, 2023-that will be used to identify and trace certain prescription drugs distributed within the United States.
Authorized manufacturers, repackagers, wholesale distributors, and dispensers involved in the pharmaceutical supply chain are eligible to participate.
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