Archive for July 11th, 2016

How to Determine the Right Regulatory Path for Combination Products

Recent FDA reforms — such as the federal agency’s lean management model and new Combination Products Policy Council — plan to simplify combination product review. However, getting a medical device to market is still a lengthy process — on average, it takes 12 years to get a product into a pharmacy — and complex.

Developing a regulatory strategy helps you align FDA regulatory requirements with your business model so you can overcome some of the challenges associated with combination product review. Read more »