How to submit a meeting package to cder food and drug. Joint meeting of the drug safety and risk management dsarm advisory committee and the anesthetic and analgesic drug products advisory committee aadpac may 34, 2016. The book should be approximately 20 to 30 pages long, and should be organized in a way that complements the sponsors oral presentations. It leads you to templates for two complete briefing books.
Formal meetings between the fda and sponsors or applicants of. This guidance discusses the principles of good meeting management practices. Briefing paper template word document the page you are accessing is a downloadable word document. Vice president, regulatory affairs hurley consulting associates ltd. Guidance on cmc for phase 1 and phases 23 investigational new drug applications charles p. Documentation submitted to facilitate an agency meeting, for example to request scientific advice in relation to a proposed drug development pathway. Formal meetings between the fda and sponsors or applicants. The ectd is the standard format for submitting applications, amendments, supplements, and reports to fda s center for drug evaluation and research cder and center for biologics evaluation and research cber. Strategies for preparing for meetings with fda susan m. Writing a briefing book for a cder advisory committee. You may retrieve this document by clicking the following link. Submit meeting package at least 1 month before formal meeting. Executive director, pfizer board member, fda alumni association. Click on any topic listed to jump directly to that topic, or click next to continue.
Joint meeting of the drug safety and risk management dsarm advisory committee and the anesthetic and analgesic drug products advisory committee aadpac may 3. Type a meeting package should be submitted with the meeting request. Under appropriate circumstances, a separate cmcspecific meeting can be held in addition to, or as an alternative to, the multidisciplinary format. Submitting a meeting request food and drug administration. The ectd is the standard format for submitting applications, amendments, supplements, and reports to fda s center for drug evaluation and research cder and center for. Submit desk paper copies of meeting packages to the regulatory project manager contact the division regarding submission format. Briefing book or briefing materials voisin consulting life sciences. It is the sponsors responsibility to prepare an fda briefing book. Briefing book for a complex engagement involving three events at one location. Preparing for an fda advisory committee meeting mddi online. Submit meeting package along with meeting request type b and c. Or bibliographyptyp or biographyptyp or pubmed booksfilter or. Guidance for industry food and drug administration.
Submit formalarchival submissions to the central document room. You might find it useful to print both of those books, add dividers and place them in binders. Ind content and format for phase 1 studies food and drug. Submitting in ectd format food and drug administration. Formal meetings with sponsors and applicants for pdufa. Guidance on cmc for phase 1 and phases 23 investigational. Meetings with cder judit milstein chief project management staff.