LATEST SIGNALS
Latest news on dietary supplement safety, adverse event reporting, MedWatch and regulatory requirements for manufacturers.
Latest update · April 6, 2026
LATEST SIGNALS
3The FDA is requiring postmarketing individual case safety report submissions to use the International Council of Harmonisation E2B(R3) data standards starting October 1, 2026, via the Electronic Submissions Gateway Next Generation.
Auto-translatedOriginal source language · Federal Register — Food and Drug AdministrationOpen original release →Read summary →The FDA has released a final guidance on postapproval safety data management, clarifying the use of new data sources and terminology for adverse event reporting, replacing a draft guidance issued in 2024 and a 2003 final guidance.
Auto-translatedOriginal source language · Federal Register — Food and Drug AdministrationOpen original release →Read summary →The FDA is seeking public comment on a proposed collection of information related to adverse event reporting by the agency on new animal drugs and product manufacturing defects, as required by the Paperwork Reduction Act of 1995.
Auto-translatedOriginal source language · Federal Register — Food and Drug AdministrationOpen original release →Read summary →