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Information for industry
- FDA issued two draft guidances furthering the agency’s implementation of the Drug Supply Chain Security Act (DSCSA), which outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. The Standardization of Data and Documentation Practices for Product Tracing draft guidance (PDF, 170 KB) elaborates on the standards for the interoperable exchange of transaction information, transaction history and transaction statements (product tracing information). The Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act draft guidance (PDF, 283 KB - comments due April 30, 2018) describes the FDA’s interpretation of terms used in the definitions of "suspect" and "illegitimate" products in the DSCSA to help trading partners meet their verification obligations, which include notifying the FDA. Also see: FDA In Brief: FDA takes steps to enhance drug supply chain security; setting new recommended data standards to identify, trace packages (February 28, 2018)
- Under the Mutual Recognition Agreement, FDA notified 4 countries (Czech Republic, Greece, Hungary & Romania) that they are recognized, based on quality, of being able to conduct inspections of manufacturing facilities that meet FDA requirements. In November 2017, 8 additional countries were notified. (March 1, 2018)
- Reminder: Comment by March 20, 2018 on draft guidance Material Threat Medical Countermeasure Priority Review Vouchers (PDF, 174 KB) Also see: FDA takes steps to spur development of medical countermeasures needed to protect, prepare for emerging threats to public health and national security and 21st Century Cures Act: MCM-Related Cures Provisions
More: MCM-Related Guidance by Date |
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