Moderna seeks FDA meeting
Moderna Inc has asked for a meeting with the US Food and Drug Administration to query the agency’s decision to refuse to review its candidate mRNA vaccine for influenza. Effective 16 February, the agency hadn’t disclosed whether or not it would consider a follow-up discussion known as a Type-A meeting. This follows an event in early February when the director of the FDA’s biologics evaluation and research division at the agency, Vinayak Prasad, issued a refusal-to-file letter to Moderna overruling the advice of career staff at the agency.
