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 »A guidance to help applicants and the review staff in the FDA's Center for Drug Evaluation and Research determine when a drug belongs to an established pharmacologic class, as well as how to select the appropriate word, phrase, or term that describes the pharmacologic class for inclusion in approved prescription drug labeling was issued by the FDA. Titled “Labeling for Human Prescription Drugs—Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information,” the guidance applies only to the use of the pharmacologic class in the Indications and Usage section of Highlights of Prescribing Information labels. The guidance finalizes a draft document of the same title announced in the Federal Register of May 16, 2007. FDA Notice. Read More
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
Everything you need to know about Food and Drug Regulations.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. Learn More » |
Medical Devices ReporterAccess the full text plus expert analysis of all laws and regulations governing the classification, approval, manufacture, and marketing of all medical diagnostic, and radiological devices. Learn More » |
