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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter A - General |
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Part 4 - Regulation of Combination Products |
| Subpart A - Current Good Manufacturing Practice Requirements for Combination Products |
| § 4.1 - What is the scope of this subpart? |
| § 4.2 - How does FDA define key terms and phrases in this subpart? |
| § 4.3 - What current good manufacturing practice requirements apply to my combination product? |
| § 4.4 - How can I comply with these current good manufacturing practice requirements for a co-packaged or single-entity combination product? |
| 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? |