Posted by Michael Wonder on 09 Oct 2018
Statement from FDA Commissioner on new efforts to advance the development of generic copies of complex drugs to improve patient access to medicines
9 October 2018 - As part of the U.S. FDA’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 “genericise” under our traditional approaches. As a result, these drugs often face less competition.
Today, we’re announcing a series of guidance documents that will advance the development of generic transdermal and topical delivery systems. 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.
