21 CFR
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 587 × 483
- § 314.81 Other postmarketing reports 237 × 483
- § 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
- § 314.200 Notice of opportunity for hearing; notice of participation and request for hearing; grant or denial of hearing
- § 314.201 Procedure for hearings
- § 314.235 Judicial review
Subpart G - Miscellaneous Provisions
- § 314.410 Imports and exports of new drugs
- § 314.420 Drug master files
- § 314.430 Availability for public disclosure of data and information in an application or abbreviated application
- § 314.440 Addresses for applications and abbreviated applications
- § 314.445 Guidance documents
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