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Regulations last checked for updates: May 23, 2025

Title 21 - Food and Drugs last revised: May 19, 2025
All TitlesTitle 21Chapter IPart 4Subpart B - Subpart B—Postmarketing Safety Reporting for Combination Products
  • § 4.100 - What is the scope of this subpart?
  • § 4.101 - How does the FDA define key terms and phrases in this subpart?
  • § 4.102 - What reports must you submit to FDA for your combination product or constituent part?
  • § 4.103 - What information must you share with other constituent part applicants for the combination product?
  • § 4.104 - How and where must you submit postmarketing safety reports for your combination product or constituent part?
  • § 4.105 - What are the postmarketing safety reporting recordkeeping requirements for your combination product or constituent part?
authority: 21 U.S.C. 321,331,351,352,353,355,360,360b-360f,360h-360j,360l,360hh-360ss,360aaa-360bbb,371,372,379e,381,383,394; 42 U.S.C. 216,262,263a,264,271
source: 78 FR 4321, Jan. 22, 2013, unless otherwise noted.
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