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FDA Action on Applications and Abbreviated Applications
Law
CFR 21
Food and Drugs
Food and Drug Administration, Department of Health and Human Services
Drugs for Human Use
Applications for FDA Approval to Market a New Drug
FDA Action on Applications and Abbreviated Applications
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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
§ 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Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn.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.