Subpart D - FDA ACTION ON APPLICATIONS AND ABBREVIATED APPLICATIONS
- Section 314.100 - Timeframes for reviewing applications and abbreviated applications
- Section 314.101 - Filing an NDA and receiving an ANDA
- Section 314.102 - Communications between FDA and applicants
- Section 314.103 - Dispute resolution
- Section 314.104 - Drugs with potential for abuse
- Section 314.105 - Approval of an NDA and an ANDA
- Section 314.106 - Foreign data
- Section 314.107 - Date of approval of a 505(b)(2) application or ANDA
- Section 314.108 - New drug product exclusivity
- Section 314.110 - Complete response letter to the applicant
- Section 314.120 - Reserved
- Section 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
- Section 314.125 - Refusal to approve an NDA
- Section 314.126 - Adequate and well-controlled studies
- Section 314.127 - Refusal to approve an ANDA
- Section 314.150 - Withdrawal of approval of an application or abbreviated application
- Section 314.151 - Withdrawal of approval of an abbreviated new drug application under section 505(j)(5) of the act
- Section 314.152 - Notice of withdrawal of approval of an application or abbreviated application for a new drug
- Section 314.153 - Suspension of approval of an abbreviated new drug application
- Section 314.160 - Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn
- Section 314.161 - Determination of reasons for voluntary withdrawal of a listed drug
- Section 314.162 - Removal of a drug product from the list
- Section 314.170 - Adulteration and misbranding of an approved drug