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New FDA Database To Aid Generic-Drug Makers' Decisions, Law360

June 28, 2019

Morgan Lewis partners Rebecca Dandeker and Jeffrey Gargano were quoted in a Law360 article regarding the expansion by the US Food and Drug Administration (FDA) of a database about applications for approval of generic drugs. The expansion will provide more information related to the 180-day period of market exclusivity available to the first applicants for a generic drug.

Reacting to the development, Rebecca told Law360, "This helps the day-to-day people in the regulatory affairs departments who are having to move their resources in order to prioritize different ANDAs that are at different stages in the process of either being developed or being approved." Jeff notes the biggest impact of the new statement will be the information it provides to generic companies "so they have a better idea of the marketing landscape, the regulatory landscape and the competitive landscape, so they're in a better position to make business decisions."

Read the full Law360 article >>