Proprietary names usage for drug products, guidance

Food, Drug and Cosmetics Law Reporter

Full-text source covering federal and state laws and regulations and court decisions that govern the safety, effectiveness, purity, packaging and labeling of food, drugs and cosmetics. Devoted primarily to the Federal Food, Drug and Cosmetic Act, the Fair Packaging and Labeling Act and the Comprehensive Drug Prevention and Control Act.

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Recommendations to industry regarding the submission of a complete package that FDA intends to use to assess the safety of proposed proprietary names for drugs, including biological products, and other factors that, in association with the name, can contribute to medication errors are provided in a guidance published by the agency. Titled “Contents of a Complete Submission for the Evaluation of Proprietary Names,” the guidance applies to prescription drug products that are the subject of an investigational new drug application (IND), new drug application (NDA), abbreviated new drug application (ANDA), biologics license application (BLA) or any nonprescription drug products that are the subject of an IND, NDA, or ANDA. The information will be used in the assessment of promotional aspects of proposed proprietary names. FDA Notice. Read More

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For more information regarding this topic, see the Food, Drug and Cosmetics Law Reporter. The Reporter provides the full-text source covering federal and state laws and regulations and court decisions that govern the safety, effectiveness, purity, packaging and labeling of food, drugs and cosmetics. Devoted primarily to the Federal Food, Drug and Cosmetic Act, the Fair Packaging and Labeling Act and the Comprehensive Drug Prevention and Control Act. Learn more.

Food, Drug and Cosmetics Law Reporter

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Full-text source covering federal and state laws and regulations and court decisions that govern the safety, effectiveness, purity, packaging and labeling of food, drugs and cosmetics.

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