Code of Federal Regulations · Subpart

Subpart B — Postmarketing Safety Reporting For Combination Products

21 C.F.R. pt. 4, subpt. B

• § 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?