Subpart D—FDA Action on Applications and Abbreviated Applications

1. CFR
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3. Title 21
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5. Chapter I
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7. Part 314
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9. Subpart D

Sections

Section numbering in the official eCFR can be non-consecutive. Omitted section numbers are not treated here as reserved unless the source explicitly labels them that way.

• 314.100
  § 314.100 Timeframes for reviewing applications and abbreviated applications.
• 314.101
  § 314.101 Filing an NDA and receiving an ANDA.
• 314.102
  § 314.102 Communications between FDA and applicants.
• 314.103
  § 314.103 Dispute resolution.
• 314.104
  § 314.104 Drugs with potential for abuse.
• 314.105
  § 314.105 Approval of an NDA and an ANDA.
• 314.106
  § 314.106 Foreign data.
• 314.107
  § 314.107 Date of approval of a 505(b)(2) application or ANDA.
• 314.108
  § 314.108 New drug product exclusivity.
• 314.110
  § 314.110 Complete response letter to the applicant.
• 314.120
  § 314.120 [Reserved]
• 314.122
  § 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
  § 314.125 Refusal to approve an NDA.
• 314.126
  § 314.126 Adequate and well-controlled studies.
• 314.127
  § 314.127 Refusal to approve an ANDA.
• 314.150
  § 314.150 Withdrawal of approval of an application or abbreviated application.
• 314.151
  § 314.151 Withdrawal of approval of an abbreviated new drug application under section 505(j)(5) of the act.
• 314.152
  § 314.152 Notice of withdrawal of approval of an application or abbreviated application for a new drug.
• 314.153
  § 314.153 Suspension of approval of an abbreviated new drug application.
• 314.160
  § 314.160 Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn.
• 314.161
  § 314.161 Determination of reasons for voluntary withdrawal of a listed drug.
• 314.162
  § 314.162 Removal of a drug product from the list.
• 314.170
  § 314.170 Adulteration and misbranding of an approved drug.