Oralair regulatory update

FDA postponed a Nov. 5-6 meeting of the Allergenic Products Advisory Committee that was scheduled to discuss 2 grass pollen allergy products due to the shutdown of the federal government. The agency said it postponed the meeting because the subject was allergenics, which are not associated with user fees. Applications for allergenic extract products are not supported by user fees, according to FDA guidance. The agency has said it will continue activities funded by carryover user fee balances during the shutdown, including advisory committee meetings "within the scope of the PDUFA, GDUFA, or MDUFA programs." ...