The Importance of Mock FDA Drug Advisory Committee Meetings: Proven Benefits, Proven Results.
The Importance of Mock FDA Drug Advisory Committee Meetings: Proven Benefits, Proven Results
Innovative Science Solutions (ISS) has over a decade of experience in preparing teams for FDA Advisory Committee (AdComm) meetings. One of the things we stress most to our clients is the importance of having at least two “mock” rehearsals. Why? Because Practice Makes Perfect!
But how do you execute a successful mock, and how do you define “successful”?
In our current Free Quarterly Giveaway, we’ll share with you the most important aspects of a Mock FDA Advisory Committee Rehearsal!
Over the past few years, the number of ex-US manufacturers submitting a Class II exempt 510k device registration has increased substantially. For companies with medical devices that are approved and successful in a foreign market, the logical next step is to introduce their product into the US, which has one of the most lucrative healthcare markets in the world. Read more
FDA advisory committee meetings are important regulatory events for many manufacturers on the path to marketing approval. These meetings can quite literally result in the approval or rejection of a product based on the panel’s vote. Read more
One of the main challenges our clients face is determining which regulatory pathway is best for their products. For example, what if an OTC product has a Monograph active ingredient but that ingredient is present at a different amount than the permitted amount? Or what if the label claims a novel indication not specified in a Monograph? If you are debating pursuit of either regulatory pathway for your OTC drug, it is critical to consider cost, timeline, and label claims to ensure your products has a unique stance in today’s market. Read more
US distributors and agents trying to import rapid antibody tests for coronavirus face a number of obstacles. The good news is that FDA has opened up the Emergency Use Authorization (EUA) program to include SARS-CoV-2 (the virus) and COVID-19 (the disease), expediting time to market. Read more
The journey to scientific and commercial success is often complex and always critical, if you are looking for an expert partner to help steer you to confident solutions, contact us todayContact us