Golden and Leongini Quoted on FDA Information Request in Country’s First OTC Daily Oral Contraceptive

HBW Insight
Partner Emily Leongini and Associate Shoshanna Golden were quoted on US Food and Drug Administration’s (FDA) request for additional information from HRA Pharma’s NDA sponsor of a proposal for the country’s first over-the-counter (OTC) daily oral contraceptive.

They said that asking an NDA sponsor for more information and delaying an advisory committee meeting isn’t outside the norm.

They also pointed out that a day before announcing the advisory panel meeting postponement for HRA Pharma’s NDA, the FDA announced two other advisory meetings for prescription drugs had also been postponed.

“Postponing advisory committee meetings is not unprecedented or that unusual — there are a variety of reasons why FDA may decide to postpone a meeting,” Emily and Shoshanna said.

They added that the other recent postponements were due to “the same reason that FDA postponed the advisory committee meeting regarding Opill,” which was “to allow time for FDA to review new information.”

“In our view, there does not seem to be anything particularly unusual or noteworthy about the postponement of this meeting,” Golden and Leongini said.

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