How generic drug sponsors can ask FDA to reconsider applications: new draft guidance explains

The FDA is clar­i­fy­ing in­stances where gener­ic drug ap­pli­cants can re­quest that the agency re­con­sid­er an ap­pli­ca­tion, ac­cord­ing to an up­dat­ed draft guid­ance pub­lished Wednes­day.

The 12-page draft guid­ance, which re­places a draft from Oc­to­ber 2017, is up­dat­ed to re­flect the re­cent­ly reau­tho­rized Gener­ic Drug User Fee Amend­ments and to clar­i­fy which mat­ters are ap­pro­pri­ate for re­con­sid­er­a­tion.

“The pro­ce­dures and poli­cies de­scribed in this guid­ance are in­tend­ed to for­mal­ize FDA’s cur­rent and his­tor­i­cal prac­tices and to con­tin­ue to pro­mote rapid and fair res­o­lu­tion of el­i­gi­ble re­quests be­tween an ap­pli­cant and FDA,” FDA wrote.

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