Advisory Committee ExpectationsThe CRL was a surprise given the prior positive recommendation from the Pulmonary-Allergy Drug Advisory Committee.
Market Entry DelaysThe FDA issued a Complete Response Letter for neffy, indicating a shift in their approval standards and resulting in a delay for the product's potential market entry.
Regulatory ChallengesARS Pharmaceuticals announced the FDA issued a Complete Response Letter (CRL) for neffy, requesting additional studies and information on nitrosamine impurities.