Article FDA Thank You FDA updates set the stage for broader use of harmonized standards for safety reporting
Agency IQ
APRIL 8, 2024
In 2012, the passage of the FDA Safety and Innovation Act (FDASIA) created a new requirement for sponsors to submit all drug submissions, including clinical trial applications, in an electronic format as specified by FDA guidance. Investigational New Drug, or IND, safety reports) to the FDA in E2B(R3) format.
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