21 CFR Subpart D - Subpart D—FDA Action on Applications and Abbreviated Applications

  1. § 314.100 Timeframes for reviewing applications and abbreviated applications.
  2. § 314.101 Filing an NDA and receiving an ANDA.
  3. § 314.102 Communications between FDA and applicants.
  4. § 314.103 Dispute resolution.
  5. § 314.104 Drugs with potential for abuse.
  6. § 314.105 Approval of an NDA and an ANDA.
  7. § 314.106 Foreign data.
  8. § 314.107 Date of approval of a 505(b)(2) application or ANDA.
  9. § 314.108 New drug product exclusivity.
  10. § 314.110 Complete response letter to the applicant.
  11. § 314.120 [Reserved]
  12. § 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.
  13. § 314.125 Refusal to approve an NDA.
  14. § 314.126 Adequate and well-controlled studies.
  15. § 314.127 Refusal to approve an ANDA.
  16. § 314.150 Withdrawal of approval of an application or abbreviated application.
  17. § 314.151 Withdrawal of approval of an abbreviated new drug application under section 505(j)(5) of the act.
  18. § 314.152 Notice of withdrawal of approval of an application or abbreviated application for a new drug.
  19. § 314.153 Suspension of approval of an abbreviated new drug application.
  20. § 314.160 Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn.
  21. § 314.161 Determination of reasons for voluntary withdrawal of a listed drug.
  22. § 314.162 Removal of a drug product from the list.
  23. § 314.170 Adulteration and misbranding of an approved drug.
Source:
50 FR 7493, Feb. 22, 1985, unless otherwise noted. Redesignated at 57 FR 17983, Apr. 28, 1992.