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Labeling Review Acceptable?
Each statement proposed for drug labeling must be justified by data and results submitted in the NDA. The Code of
Federal Regulations (CFR) describes labeling requirements in 21 CFR Part 201- Labeling. The labeling is organized in the
following sections:
| Description |
Proprietary and established name of drug; dosage form; ingredients; chemical name; and structural
formula. |
| Clinical Pharmacology |
Summary of the actions of the drug in humans; in vitro and in vivo actions in animals if pertinent to
human therapeutics; pharmacokinetics. |
| Indications and Usage |
Description of use of drug in the treatment, prevention or diagnosis of a recognized disease or condition. |
| Contraindications |
Description of situations in which the drug should not be used because the risk of use clearly outweighs
any possible benefit. |
| Warnings |
Description of serious adverse reactions and potential safety hazards, subsequent limitation in use, and
steps that should be taken if they occur. |
| Precautions |
Information regarding any special care to be exercised for the safe and effective use of the drug.
Includes general precautions and information for patients on drug interactions, carcinogenesis/mutagenesis, pregnancy
rating, labor and delivery, nursing mothers, and pediatric use. |
| Adverse Reactions |
Description of undesirable effect(s) reasonably associated with the proper use of the drug. |
| Drug Abuse/ Dependence |
Description of types of abuse that can occur with the drug and the averse reactions pertinent to them. |
| Overdosage |
Description of the signs, symptoms and laboratory findings of acute overdosage and the general principles
of treatment. |
| Dosage/ Administration |
Recommendation for usage dose, usual dosage range, and, if appropriate, upper limit beyond which safety
and effectiveness have not been established. |
| How Supplied |
Information on the available dosage forms to which the labeling applies. |
Source: U.S. Food and Drug Administration Center for Drug Evaluation and Research Handbook.
Back to The New Drug Development Process
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