Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
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FDA Panel Takes ‘Leap Of Faith’ In Backing Epinephrine Nasal Spray For Anaphylaxis
In a split vote, advisory committee finds PK/PD data support favorable benefit-risk assessment of ARS Pharmaceuticals’ neffy, but calls for postmarket studies to evaluate its clinical efficacy.
Sarepta’s DMD Gene Therapy: FDA Says Concluding Effectiveness Or Ineffectiveness Is ‘Challenging’
Concerns about the clinical trials, the manufacturing, and the preclusive nature of Sarepta's gene therapy for Duchenne muscular dystrophy raise questions ahead of the upcoming US FDA advisory committee meeting.
First OTC Oral Contraceptive Has Advisory Panel’s Unanimous Support Despite FDA’s Data Concerns
FDA officials again made clear concerns about “improbable dosing” data in HRA’s sNDA for 0.075-mg norgestrel tablet branded Opill before advisory panel voted at close of a two-day meeting conducted 60 years after first Rx oral contraceptive approved in US.