Federal (United States) · Regulations
Subpart B
5 sections
5 sections
- 21 C.F.R. § 4.101How does the FDA define key terms and phrases in this subpart?
- 21 C.F.R. § 4.102What reports must you submit to FDA for your combination product or constituent part?
- 21 C.F.R. § 4.103What information must you share with other constituent part applicants for the combination product?
- 21 C.F.R. § 4.104How and where must you submit postmarketing safety reports for your combination product or constituent part?
- 21 C.F.R. § 4.105What are the postmarketing safety reporting recordkeeping requirements for your combination product or constituent part?