Federal (United States) · Regulations
Subpart D — FDA Action on Applications and Abbreviated Applications
22 sections
22 sections
- 21 C.F.R. § 314.100Timeframes for reviewing applications and abbreviated applications.
- 21 C.F.R. § 314.101Filing an NDA and receiving an ANDA.
- 21 C.F.R. § 314.102Communications between FDA and applicants.
- 21 C.F.R. § 314.103Dispute resolution.
- 21 C.F.R. § 314.104Drugs with potential for abuse.
- 21 C.F.R. § 314.105Approval of an NDA and an ANDA.
- 21 C.F.R. § 314.106Foreign data.
- 21 C.F.R. § 314.107Date of approval of a 505(b)(2) application or ANDA.
- 21 C.F.R. § 314.108New drug product exclusivity.
- 21 C.F.R. § 314.110Complete response letter to the applicant.
- 21 C.F.R. § 314.122Submitting an abbreviated application for, or a 505(j)(2)(C) petition that relies on, a listed drug that is no longer marketed.
- 21 C.F.R. § 314.125Refusal to approve an NDA.
- 21 C.F.R. § 314.126Adequate and well-controlled studies.
- 21 C.F.R. § 314.127Refusal to approve an ANDA.
- 21 C.F.R. § 314.150Withdrawal of approval of an application or abbreviated application.
- 21 C.F.R. § 314.151Withdrawal of approval of an abbreviated new drug application under section 505(j)(5) of the act.
- 21 C.F.R. § 314.152Notice of withdrawal of approval of an application or abbreviated application for a new drug.
- 21 C.F.R. § 314.153Suspension of approval of an abbreviated new drug application.
- 21 C.F.R. § 314.160Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn.
- 21 C.F.R. § 314.161Determination of reasons for voluntary withdrawal of a listed drug.
- 21 C.F.R. § 314.162Removal of a drug product from the list.
- 21 C.F.R. § 314.170Adulteration and misbranding of an approved drug.