New Drug Application - Labeling Review
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. |
Featured Products
3-hr Virtual Seminar: An Introduction to the FDA New Drug Approval Process
This 3-hr virtual seminar on the FDA New Drug Approval Process will cover the NDA and ANDA review and approval process including a discussion of preparing NDAs and ANDAs, relevant meetings, timing, costs, approval requirements and other FDA regulatory requirements. The various existing regulatory approval pathways (the “full” NDA, the 505(b)(2) NDA and the ANDA) will be discussed.
This 3-hr virtual seminar on the FDA New Drug Approval Process will cover the NDA and ANDA review and approval process including a discussion of preparing NDAs and ANDAs, relevant meetings, timing, costs, approval requirements and other FDA regulatory requirements. The various existing regulatory approval pathways (the “full” NDA, the 505(b)(2) NDA and the ANDA) will be discussed.
Biomarkers for Drug Development: The Emerging Regulatory Landscape
This training provides an up-to-date understanding of regulatory requirements for the development and implementation of biomarkers in drug development programs, as well as highlights of the most recent FDA sources on general, imaging (Including PET) and pharmacogenomic biomarkers.
This training provides an up-to-date understanding of regulatory requirements for the development and implementation of biomarkers in drug development programs, as well as highlights of the most recent FDA sources on general, imaging (Including PET) and pharmacogenomic biomarkers.
Drug Safety Assessment and Risk Minimization in the Development Period
Drug safety training - factors to be considered - drug development - risk management - intellectual property - pharmacovigilance
Drug safety training - factors to be considered - drug development - risk management - intellectual property - pharmacovigilance
