Read the full guidance: Design Considerations for Devices Intended for Home Use – Guidance for Industry and Food and Drug Administration Staff (PDF – 205KB) As stated in the guidance, “This guidance is intended to assist manufacturers in designing and developing home use devices that comply with applicable standards of safety and effectiveness and other […]
Tag: FDA
FDA Law Blog: And So It Begins: FDA Issues First DSCSA Guidance
The FDA just published: Guidance for Industry – Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification (PDF) William Koustas (FDA Law Blog) writes, “The DSCSA tasked FDA with addressing three issues in this guidance: (1) identifying scenarios that could increase the risk of suspect product entering the supply chain; (2) recommending […]
The Differences Between The DSCSA, FDA Rules and Guidance – RxTrace
How To Approach, Read, and Interpret the DSCSA Another great educational snippet from Dirk Rodgers (RxTrace). Follow the link below to read his full article. “So let’s apply that to the exchange of Transaction Information TI, Transaction History TI, and Transaction Statements TS that all U.S. pharma supply chain trading partners must do beginning on […]
FDA DSCSA Workshop – Meeting Materials
Follow the link below to the FDA webpage of all related meeting materials and notices: “[This FDA public workshop, May 8-9, 2014, was] intended to gather information, current practices, research and ideas on the standards for the exchange of transaction information, transaction history and transaction statements, in paper or electronic format, for each transfer of […]
FDA Law Blog: Interoperably Exchanging Information with FDA: Agency Holds First DSCSA Public Workshop
Follow the link below for a sobering report of the FDA’s first DSCSA public workshop, and the short implementation timeline that faces the supply chain: “Without an issued guidance, however, what are supply chain members to do in the meantime? Perhaps the most important thing to do is to try to understand the DSCSA, and how different […]