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FDA Commissioner Scott Gottlieb announces efforts to advance 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, US FDA Commissioner Scott Gottlieb has said that the agency has advanced many policies aimed at making it more efficient to bring generic competition to the market. 

By Team ABLE

As part of the U.S. Food and Drug Administration’s efforts to promote drug competition and patient access, US FDA Commissioner Scott Gottlieb has said that the agency has advanced many policies aimed at making it more efficient to bring generic competition to the market. 

Gottlieb said, “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.” 

FDA has announced a series of guidance documents that will advance the development of generic transdermal and topical delivery systems (TDS). The increased transparency and predictability provided by these and other product-specific recommendations gives applicants seeking to develop generic copies of these complex products a better opportunity to efficiently advance these products and prepare better and more complete submissions, says Gottlieb. 

For further details visit US FDA website.