Simplifying Global Compliance
Yes, you can speed up your company's drug approval time — by using the 505(b)(2) process. Unsure of how to use the 505(b)(2) process? Here's an opportunity to get all the details in a new report available from FDAnews.
With countless forms and steps necessary to get a medical device approved, many organizations become frustrated when a device is rejected from entering the market. Learn what you need to do to pass your 510(k) submission the first time.
Industry experts Kevin Nelson and Dr. Patrick Gallagher from Duane Morris LLP use examples from leading companies that are currently attempting to demonstrate biosimilarity. Learn how the FDA’s thinking about clinical requirements for demonstrating biosimilarity is evolving.
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