AI platforms grow to improve pharma’s regulatory workflows

Pharmaceutical companies are increasingly using artificial intelligence to improve drug approval processes with regulatory authorities. AI platforms analyze past decisions from regulators like the FDA to predict what questions regulators will ask on approval applications and help drug developers identify weaknesses in their submissions before filing. According to 2014 FDA data, half of new drug approval applications failed on the first attempt, and successful resubmissions took a median of 435 days. Companies like Peer AI are developing platforms that anticipate regulatory questions, shifting the process from reactive to proactive. Large pharmaceutical companies such as Novo Nordisk are testing AI to optimize how they submit documentation and adapt to different regional regulators' requirements. The FDA launched its generative AI tool Elsa in June 2025 to accelerate the review of submissions. The future promises an end-to-end AI pipeline from clinical trials to drug approval.