Workshop on Drug Supply Chain Pilot

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Federal Register Notice: FDA will hold a public workshop 4/5 entitled “Proposed Pilot Project(s) under the Drug Supply Chain Security Act (DSCSA).” It will provide a forum for discussing proposed design objectives of pilot projects that will explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain. FDA would like to obtain information and input from interested pharmaceutical distribution supply chain members about issues related to utilizing the product identifier for product tracing, improving the technical capabilities of the supply chain, and identifying the system attributes that are necessary to implement the requirements established under the DSCSA. The workshop will be held 4/5, from 9 a.m. to 5 p.m. and 4/6, from 9 a.m. to 12:15 p.m. Contact Daniel Bellingham, (301) 796-3130. To view this notice, click here.

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Guide on Biosimilar Postapproval Manufacturing Changes

FDA has released a final guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products — Questions and Answers.” The document explains how manufacturers should document and report changes to approved biosimilars, including changes involving manufacturing processes, production facilities, dosage forms and strengths. Regarding information required for postapproval manufacturing changes,