What is briefing document FDA?
Abstract. Health authority briefing documents (also known as briefing packs, briefing packages, and briefing books) are documents prepared by a pharmaceutical company to support its interactions (e.g. pre-submission meetings, requests for scientific advice, and protocol assistance) with health authorities.
How do I prepare for a FDA meeting?
Outline and rehearse contingency plans. Consider the need for a formal presentation. Critically evaluate preliminary feedback from the FDA and the implications for your program. Prepare follow-up discussion points, questions, and “fallback positions” on key questions at the meeting.
What is Type C meeting with FDA?
A Type C meeting is any meeting other than a Type A or Type B meeting between CBER or CDER and a sponsor or applicant regarding the development and review of a product.
What is a briefing book?
A briefing book provides a decision maker with an overview of an issue or problem, normally in support of policy findings or recommendations. Briefing books are often accompanied by oral briefings that present the most important findings or recommendations.
What is a pre NDA meeting?
The pre-NDA meeting is typically the last formal interaction with the FDA prior to NDA submission. This meeting is an opportunity to solicit comments and clarification from the FDA on the acceptability of: Key clinical data, including data that might become available for submission during NDA review.
What is end of Phase 2 meeting?
The purpose of an end-of-phase 2 meeting is to determine the safety of proceeding to Phase 3, to evaluate the Phase 3 plan and protocols and the adequacy of current studies and plans to assess pediatric safety and effectiveness, and to identify any additional information necessary to support a marketing application for …
What is a Type B Meeting with FDA?
Type B meetings, which are routine meetings occurring at pre-defined endpoints between FDA and a sponsor. Meetings typically occur right after or right before the submission of clinical data or a new drug filing.
What is Type B Meeting with FDA?
What is a 505 B 1 application?
The 505(b)(1) regulatory pathway is the traditional New Drug Application (NDA). This pathway is used by Sponsors to obtain the approval of a new drug whose active ingredients have not previously been approved.
Does FDA accept paper submissions?
Non-commercial IND submissions (including investigator-sponsored INDs and expanded access INDs) are exempt. After these deadlines, paper submissions or electronic submissions that are NOT in eCTD format will NOT be filed or received unless exempt from the requirement.
