Scientific advice

This branch covers the scientific advice a sponsor seeks from a regulatory agency on the tests and trials a medicine's development needs, through scientific advice or protocol assistance at the European Medicines Agency or a formal meeting with the FDA, and the writing that asks for it. Its parts divide by the question the work answers: what the advice can and cannot settle, which route to it fits a programme, how the briefing package that opens the interaction is written, and when each part of that package is due. Why and when the dialogue with an agency is opened during development, the answers to the questions an agency raises in review, and the application the advice prepares for are left to the branch's neighbours.

• What scientific advice can and cannot settle — who gives European advice and on what basis, what it covers and what it binds, when to seek it and who seeks it, the outcomes of following it, and what a sponsor does where no advice procedure exists
• Scientific-advice routes beyond the standard procedure — early orientation for an innovative or unclassified product, parallel advice with health technology assessment bodies and with the FDA, PRIME, advice informed by a biosimilar's data, qualification of a novel methodology, national advice, accelerated advice in a public health emergency, and advice for repurposing
• Scientific-advice briefing documents — writing the package that opens a formal interaction: its purpose, guidance and contents, the medical writer's part, preparing it, framing questions that are precise, in scope and few, the EMA briefing book and the FDA briefing package and how they differ, and who reads it
• Scientific-advice and meeting timelines — when the request, the draft and the final package are due under the US formal-meeting types, the European advice calendar, and the parallel-advice and qualification procedures