Get Memorandum FDA Panel Summary - Food And Drug Administration - Fda

Print drug advertisements must contain a "brief summary" to summarize all of a drug's adverse effects based on the prescribing information. These summaries do not need to include non-risk information about a medication, such as the mechanism of action, etc.

Instead, FDA outlines an alternative disclosure approach they call a “consumer brief summary.” FDA's guidance encourages consumer-friendly language. “The consumer brief summary should be written in language designed for understanding by a broad target audience with various levels of literacy skill,” the agency states.

The law requires that print ads making claims about a drug (product claim ads) include a "brief summary" with all the risks listed in the drug's "prescribing information" and at least one FDA-approved use of the drug. The brief summary generally includes: Who should not take the drug.

The law requires that print ads making claims about a drug (product claim ads) include a "brief summary" with all the risks listed in the drug's "prescribing information" and at least one FDA-approved use of the drug. The brief summary generally includes: Who should not take the drug. When the drug should not be taken.

The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation.

Advisory Committee members include: Scientific experts, including physician-researchers, statisticians, engineers, medical faculty, chemists, biologists, and other science-oriented professionals. Consumer representative. Industry representative.

Pursuant to a Memorandum of Understanding between the two agencies, FDA has primary responsibility over claims that appear on labeling, while FTC has primary responsibility for claims made in advertising. Both agencies require health-related marketing to be truthful and substantiated.

The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.