Principal deputy commissioner Amy Abernethy cites IND safety reporting and oncology review pilot program as areas that would benefit from enabling receipt of sponsor data in real time; plan describes near-term strategy for modernizing agency’s technical infrastructure, developing technology tools around regulatory ‘use cases’ and improving collaborations with data and tech companies.

Aimmune’s oral immunotherapy seems destined to come to market with a strict REMS, though analysts do not expect this will impact adoption. DBV is awaiting word on whether the FDA will review its second attempt at a BLA submission for Viaskin Peanut.

Richard Pazdur tells the Pink Sheet that program for concurrent submission of oncology applications and collaborative review by global regulators also could speed approval in smaller countries; first applications under Project Orbis were for use of Lenvima/Keytruda combination for endometrial cancer in US, Canada, and Australia.

The agency’s plan to require a Risk Evaluation and Mitigation Strategy aimed at systemic allergic reactions with the peanut allergy immunotherapy did not go far enough, advisory committee members said, pushing for additional measures to be folded into the program.

The last time representatives from Amarin and US FDA formally met in public, it was in court.

Palforzia was associated with a higher rate of adverse events, systemic allergic reactions, eosinophilic esophagitis and epinephrine use in controlled clinical trials; Allergenic Products Advisory Committee will weigh approval for patients ages 4-17 years with confirmed peanut allergy diagnosis.