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Food, Drug and Cosmetics Law Reporter

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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.

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Medical Devices Reporter

Access 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.

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Topic Spotlight

Opioid REMS comment period reopened

The FDA reopened until October 19, 2010, the comment period of a public meeting held on May 27 and 28, 2009, to solicit input on developing Risk Evaluation and Mitigation Strategies (REMS) for certain opioid drugs.

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Topic Spotlight

Pharmacologic class descriptions guidance issued

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.

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