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X-WR-CALNAME:Electronic Submission of Postmarketing Individual Case Safet
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UID:2026-06660-close@docket-clock.pages.dev
DTSTAMP:20261017T145145Z
DTSTART;VALUE=DATE:20261001
DTEND;VALUE=DATE:20261002
SUMMARY:FDA comments close: Electronic Submission of Postmarketing Individ
 ual Case Safety Reports to the Food and Drug Administration Adverse Event
  Monitoring System Using International Council of Harmonisation E2B(R3) D
 ata Standards\; Regional Data Elements and Implementation Schedule
DESCRIPTION:Notice. Federal Register 2026-06660. Docket FDA-2016-D-1280. D
 etails: https://docket-clock.pages.dev/doc/2026-06660/ Official: https://
 www.federalregister.gov/documents/2026/04/06/2026-06660/electronic-submis
 sion-of-postmarketing-individual-case-safety-reports-to-the-food-and-drug
URL:https://www.federalregister.gov/documents/2026/04/06/2026-06660/electr
 onic-submission-of-postmarketing-individual-case-safety-reports-to-the-fo
 od-and-drug
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