Posted by Michael Wonder on 13 Sep 2018
FDA issues 54 product-specific guidances to promote generic drug access and drug price competition
13 September 2018 - The U.S. FDA today announced a new set of product-specific guidances to support industry in identifying appropriate science-based methodologies and evidence for developing generic drugs.
The batch contains 54 product-specific guidances, including 42 new guidances and 12 revised guidances that, when finalised, will describe the FDA’s current thinking and expectations on how to develop generic drugs that are therapeutically equivalent to their respective reference-listed drugs.
Of the guidances issued today, 12 are new draft guidances and six are revised guidances for complex drug products, including 14 products that, to date, do not have generic competition.
