Federal (United States) · Regulations
Subpart D
2 sections
2 sections
- 21 C.F.R. § 310.305Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications.
- 21 C.F.R. § 310.306Notification of a permanent discontinuance or an interruption in manufacturing of marketed prescription drugs for human use without approved new drug applications.