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Postmarketing Safety Reporting for Combination Products | Midpage
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Code of Federal Regulations
Title 21
Chapter I
Subchapter A
Part 4
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?