How New Acne Drugs Are Developed

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The U.S. Food and Drug Administration (FDA) states its purpose in the following mission statement:

“The 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 nations food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.”

In 2005 the FDA provided a public draft guidance document to the pharmaceutical industry on the development of drugs to treat acne vulgaris, or acne. The draft guidance document contains the FDA’s current thinking on the development of acne drugs and the methods that should be used.

Some of the guidance document information is summarized below. At the time of this writing the FDA document had not been finalized.

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