Subpart D - FDA Action on Applications and Abbreviated Applications
- § 314.100 Timeframes for reviewing applications and abbreviated applications
- § 314.101 Filing an NDA and receiving an ANDA
- § 314.102 Communications between FDA and applicants
- § 314.103 Dispute resolution
- § 314.104 Drugs with potential for abuse
- § 314.105 Approval of an NDA and an ANDA
- § 314.106 Foreign data
- § 314.107 Date of approval of a 505(b)(2) application or ANDA
- § 314.108 New drug product exclusivity
- § 314.110 Complete response letter to the applicant
- § 314.120 [Reserved]
- § 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 NDA
- § 314.126 Adequate and well-controlled studies
- § 314.127 Refusal to approve an ANDA
- § 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314.160 Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn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