Innovative Science Solutions (ISS), world-renowned for its FDA AdComm support expertise, is thrilled to announce that we are launching.
Millions of dollars could be riding on the outcome of an FDA Drugs Advisory Committee (AdComm) review meeting. Any misstep could affect drug approval likelihood and timing.
So what’s a company to do? Be prepared.
Innovative Science Solutions (ISS), world-renowned for its FDA AdComm support expertise, is thrilled to announce that we are launching a new blog designed specifically to deliver the information you need to be up-to-date on drug-related FDA AdComms.
Information we’ll be posting on a regular basis includes:
With this blog, ISS hopes to provide you with comprehensive AdComm information, insights that you won’t find elsewhere, and unique AdComm preparation tools. Subscribe today!
ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact firstname.lastname@example.org.
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