Dialogue with the agency

A sponsor exchanges information with the regulatory agency throughout a medicine's development, through the review of its dossier and on once the medicine is marketed, and the writing for it prepares one of those exchanges or answers it. This branch covers that dialogue, and its parts divide by the exchange the work serves: the contact a sponsor keeps with the authority from before its first application to test a medicine in people through to safety once the medicine is marketed, the scientific advice it seeks on the tests and trials development needs, and the written responses to the questions an agency raises while it reviews a dossier. It leaves the application these exchanges lead to, and the procedures it runs through, to applications and authorisation procedures, and the running of a submission as a project to managing regulatory documents.

• Talking to the authority during development — why early contact helps, the exchanges at each stage of development, the months before an investigational new drug application, meeting rehearsals and the minutes that record the outcome, the FDA and the EMA as counterparts, and safety and the balance of benefit and risk once the medicine is marketed
• Scientific advice — what scientific advice can and cannot settle, the routes to it beyond the standard procedure, the briefing package that opens a formal interaction with the EMA or the FDA, and the timelines that package is written against
• Responding to a health authority's questions in review — what the questions are and what answering them achieves, the kinds of question, when each agency asks and how long it allows, the response team and its preparation before the questions arrive, the response documents and their templates, driving the response cycle to its deadline, reading each question, writing the response and its tone, and what a medical writer adds