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- 21 CFR 314.151 · Withdrawal of approval of an abbreviated new drug application under section 505(j)(5) of the act.
- 21 CFR 314.152 · Notice of withdrawal of approval of an application or abbreviated application for a new drug.
- 21 CFR 314.153 · Suspension of approval of an abbreviated new drug application.
- 21 CFR 314.160 · Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn.
- 21 CFR 314.161 · Determination of reasons for voluntary withdrawal of a listed drug.
- 21 CFR 314.162 · Removal of a drug product from the list.
- 21 CFR 314.170 · Adulteration and misbranding of an approved drug.
- 21 CFR 314.200 · Notice of opportunity for hearing; notice of participation and request for hearing; grant or denial of hearing.
- 21 CFR 314.201 · Procedure for hearings.
- 21 CFR 314.235 · Judicial review.
- 21 CFR 314.410 · Imports and exports of new drugs.
- 21 CFR 314.420 · Drug master files.
- 21 CFR 314.430 · Availability for public disclosure of data and information in an application or abbreviated application.
- 21 CFR 314.440 · Addresses for applications and abbreviated applications.
- 21 CFR 314.445 · Guidance documents.
- 21 CFR 314.500 · Scope.
- 21 CFR 314.510 · Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.
- 21 CFR 314.520 · Approval with restrictions to assure safe use.
- 21 CFR 314.530 · Withdrawal procedures.
- 21 CFR 314.540 · Postmarketing safety reporting.
- 21 CFR 314.550 · Promotional materials.
- 21 CFR 314.560 · Termination of requirements.
- 21 CFR 314.600 · Scope.
- 21 CFR 314.610 · Approval based on evidence of effectiveness from studies in animals.
- 21 CFR 314.620 · Withdrawal procedures.
- 21 CFR 314.630 · Postmarketing safety reporting.
- 21 CFR 314.640 · Promotional materials.
- 21 CFR 314.650 · Termination of requirements.
- 21 CFR 315.1 · Scope.
- 21 CFR 315.2 · Definition.
- 21 CFR 315.3 · General factors relevant to safety and effectiveness.
- 21 CFR 315.4 · Indications.
- 21 CFR 315.5 · Evaluation of effectiveness.
- 21 CFR 315.6 · Evaluation of safety.
- 21 CFR 316.1 · Scope of this part.
- 21 CFR 316.2 · Purpose.
- 21 CFR 316.3 · Definitions.
- 21 CFR 316.4 · Address for submissions.
- 21 CFR 316.10 · Content and format of a request for written recommendations.
- 21 CFR 316.12 · Providing written recommendations.
- 21 CFR 316.14 · Refusal to provide written recommendations.
- 21 CFR 316.20 · Content and format of a request for orphan-drug designation.
- 21 CFR 316.21 · Verification of orphan-drug status.
- 21 CFR 316.22 · Permanent-resident agent for foreign sponsor.
- 21 CFR 316.23 · Timing of requests for orphan-drug designation; designation of already approved drugs.
- 21 CFR 316.24 · Deficiency letters and granting orphan-drug designation.
- 21 CFR 316.25 · Refusal to grant orphan-drug designation.
- 21 CFR 316.26 · Amendment to orphan-drug designation.
- 21 CFR 316.27 · Change in ownership of orphan-drug designation.
- 21 CFR 316.28 · Publication of orphan-drug designations.
- 21 CFR 316.29 · Revocation of orphan-drug designation.
- 21 CFR 316.30 · Annual reports of holder of orphan-drug designation.
- 21 CFR 316.31 · Scope of orphan-drug exclusive approval.
- 21 CFR 316.34 · FDA recognition of exclusive approval.
- 21 CFR 316.36 · Insufficient quantities of orphan drugs.
- 21 CFR 316.40 · Treatment use of a designated orphan drug.
- 21 CFR 316.50 · Guidance documents.
- 21 CFR 316.52 · Availability for public disclosure of data and information in requests and applications.
- 21 CFR 317.1 · [Reserved]
- 21 CFR 317.2 · List of qualifying pathogens that have the potential to pose a serious threat to public health.
- 21 CFR 320.1 · Definitions.
- 21 CFR 320.21 · Requirements for submission of bioavailability and bioequivalence data.
- 21 CFR 320.22 · Criteria for waiver of evidence of in vivo bioavailability or bioequivalence.
- 21 CFR 320.23 · Basis for measuring in vivo bioavailability or demonstrating bioequivalence.
- 21 CFR 320.24 · Types of evidence to measure bioavailability or establish bioequivalence.
- 21 CFR 320.25 · Guidelines for the conduct of an in vivo bioavailability study.
- 21 CFR 320.26 · Guidelines on the design of a single-dose in vivo bioavailability or bioequivalence study.
- 21 CFR 320.27 · Guidelines on the design of a multiple-dose in vivo bioavailability study.
- 21 CFR 320.28 · Correlation of bioavailability with an acute pharmacological effect or clinical evidence.
- 21 CFR 320.29 · Analytical methods for an in vivo bioavailability or bioequivalence study.
- 21 CFR 320.30 · Inquiries regarding bioavailability and bioequivalence requirements and review of protocols by the Food and Drug Administration.
- 21 CFR 320.31 · Applicability of requirements regarding an “Investigational New Drug Application.”
- 21 CFR 320.32 · Procedures for establishing or amending a bioequivalence requirement.
- 21 CFR 320.33 · Criteria and evidence to assess actual or potential bioequivalence problems.
- 21 CFR 320.34 · Requirements for batch testing and certification by the Food and Drug Administration.
- 21 CFR 320.35 · Requirements for in vitro testing of each batch.
- 21 CFR 320.36 · Requirements for maintenance of records of bioequivalence testing.
- 21 CFR 320.38 · Retention of bioavailability samples.
- 21 CFR 320.63 · Retention of bioequivalence samples.
- 21 CFR 328.1 · Scope.
- 21 CFR 328.3 · Definitions.
- 21 CFR 328.10 · Alcohol.
- 21 CFR 328.50 · Principal display panel of all OTC drug products intended for oral ingestion that contain alcohol.
- 21 CFR 329.100 · Postmarketing reporting of adverse drug events under section 760 of the Federal Food, Drug, and Cosmetic Act.
- 21 CFR 330.1 · General conditions for general recognition as safe, effective and not misbranded.
- 21 CFR 330.2 · Pregnancy-nursing warning.
- 21 CFR 330.3 · Imprinting of solid oral dosage form drug products.
- 21 CFR 330.5 · Drug categories.
- 21 CFR 330.10 · Procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded, and for establishing monographs.
- 21 CFR 330.11 · NDA deviations from applicable monograph.
- 21 CFR 330.12 · Status of over-the-counter (OTC) drugs previously reviewed under the Drug Efficacy Study (DESI).
- 21 CFR 330.13 · Conditions for marketing ingredients recommended for over-the-counter (OTC) use under the OTC drug review.
- 21 CFR 330.14 · Additional criteria and procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded.
- 21 CFR 330.15 · Timelines for FDA review and action on time and extent applications and safety and effectiveness data submissions.
- 21 CFR 331.1 · Scope.
- 21 CFR 331.10 · Antacid active ingredients.
- 21 CFR 331.11 · Listing of specific active ingredients.
- 21 CFR 331.15 · Combination with nonantacid active ingredients.
- 21 CFR 331.20 · Determination of percent contribution of active ingredients.
- 21 CFR 331.21 · Test modifications.