Part 314 — Applications for FDA Approval to Market a New Drug
Subpart A — General Provisions
Subpart B — Applications
- § 314.50— Content and format of an NDA.
- § 314.52— Notice of certification of invalidity, unenforceability, or noninfringement of a patent.
- § 314.53— Submission of patent information.
- § 314.54— Procedure for submission of a 505(b)(2) application requiring investigations for approval of a new indication for, or other change from, a listed drug.
- § 314.55— Pediatric use information.
- § 314.56— Nonprescription drug product with an additional condition for nonprescription use (ACNU).
- § 314.60— Amendments to an unapproved NDA, supplement, or resubmission.
- § 314.65— Withdrawal by the applicant of an unapproved application.
- § 314.70— Supplements and other changes to an approved NDA.
- § 314.71— Procedures for submission of a supplement to an approved application.
- § 314.72— Change in ownership of an application.
- § 314.80— Postmarketing reporting of adverse drug experiences.
- § 314.81— Other postmarketing reports.
- § 314.90— Waivers.
Subpart C — Abbreviated Applications
- § 314.92— Drug products for which abbreviated applications may be submitted.
- § 314.93— Petition to request a change from a listed drug.
- § 314.94— Content and format of an ANDA.
- § 314.95— Notice of certification of invalidity, unenforceability, or noninfringement of a patent.
- § 314.96— Amendments to an unapproved ANDA.
- § 314.97— Supplements and other changes to an approved ANDA.
- § 314.98— Postmarketing reports.
- § 314.99— Other responsibilities of an applicant of an ANDA.
Subpart D — FDA Action on Applications and Abbreviated Applications
- § 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.
- § 314.122— 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.
Subpart E — Hearing Procedures for New Drugs
Subpart G — Miscellaneous Provisions
Subpart H — Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses
- § 314.500— Scope.
- § 314.510— Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.
- § 314.520— Approval with restrictions to assure safe use.
- § 314.530— Withdrawal procedures.
- § 314.540— Postmarketing safety reporting.
- § 314.550— Promotional materials.
- § 314.560— Termination of requirements.