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314.160—Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn.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