While there is now a marketed biosimilar, a formal biosimilar approval pathway, and FDA guidance documents for biosimilars, the FDA is still grappling with this relatively new approval pathway. This article highlights some of the unique and important aspects Sponsors must consider when preparing for a biosimilar FDA Advisory Committee meeting. It also includes recommendations from 3D Communications on how to address these considerations.
FDA Advisory Committee members play a major role in deciding the fate of your drug or device. There is no better way to prepare for an Advisory Committee meeting than with realistic mock Advisory Committee meetings. A mock meeting that closely mimics what your team will face on the day of the FDA Advisory Committee meeting will challenge and truly prepare them. In this post, we discuss how to run a mock meeting like the real thing to maximize its success.
An FDA Advisory Committee consists of people with various levels of expertise, experience, and interests. Because of that, your team must be prepared to answer a wide range of questions to convince the Committee to recommend approval. In preparing for such a unique and challenging meeting, you’ll need to hold realistic mock meetings. Below are some tips to maximize these rehearsals.
On April 13, 2015, FDA issued two final guidance documents on premarket approval of new medical devices. These documents represent the Agency’s current thinking on when data collection might be pushed from pre-approval to post-approval, with one guidance focused on expedited approval for devices that meet a significant unmet medical need. The following is a summary of the information provided and recommendations for Sponsors looking to take advantage of opportunities to achieve earlier and less expensive medical device approval.