Former FDA oncology chief Richard Pazdur told reporters he resigned after being pressured to endorse reduced clinical-trial requirements, saying he was handed a press release "with a quotation by myself written in it, and asked to just agree to it." Pazdur criticized recent changes that permit single-trial approvals and warned the commissioner’s office has intruded on review staff functions. Separately, Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, faces internal complaints over conduct and is under scrutiny after overruling staff to return a refusal-to-file letter to Moderna for an influenza vaccine candidate. Moderna publicly disputed Prasad’s decision and its CEO defended the original study design. Why it matters: the dual reports point to internal friction at FDA leadership levels and raise questions about procedural independence in drug and biologic review. Industry stakeholders and companies preparing submissions should expect heightened political and personnel scrutiny during reviews.