21 CFR Subpart D
FDA Action on Applications and Abbreviated Applications
June 25, 2020
§
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Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn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
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