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Efforts to Advance the Development of Generic Copies of Complex Drugs

As part of the U.S. Food and Drug Administration’s efforts to promote drug competition and patient access, we’ve advanced many policies aimed at making it more efficient to bring generic competition to the market. We have been especially focused on a category of medicines known as complex drugs. These are drugs that, by nature of their formulation or delivery systems for example, are harder to “genericize” under our traditional approaches. As a result, these drugs often face less competition.