21 CFR Part 4 - Subpart B - Postmarketing Safety Reporting for Combination Products
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- § 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?
Source:
81 FR 92624, Dec. 20, 2016, unless otherwise noted.