Transdermal Patch - Regulatory Aspects

Regulatory Aspects

A transdermal patch is classified by the U.S. Food and Drug Administration as a combination product, consisting of a medical device combined with a drug or biological product that the device is designed to deliver. Prior to sale in the United States, any transdermal patch product must apply for and receive approval from the Food and Drug Administration, demonstrating safety and efficacy for its intended use.

Read more about this topic:  Transdermal Patch

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