Federal (United States) · Regulations
Subpart B — Applications
8 sections
8 sections
- 21 C.F.R. § 314.50Content and format of an NDA.
- 21 C.F.R. § 314.52Notice of certification of invalidity, unenforceability, or noninfringement of a patent.
- 21 C.F.R. § 314.53Submission of patent information.
- 21 C.F.R. § 314.55Pediatric use information.
- 21 C.F.R. § 314.72Change in ownership of an application.
- 21 C.F.R. § 314.80Postmarketing reporting of adverse drug experiences.
- 21 C.F.R. § 314.81Other postmarketing reports.
- 21 C.F.R. § 314.90Waivers.