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Choose the Right Drug Approval Pathway: Is a 505(b)(2) the Way to Go?
Section 505(b)(2) was written to help sponsors like you.
For example new and costly trials that duplicate studies already performed on a reference drug may not be necessary. So, your company could get a break and only have to provide a limited number of clinical studies (or smaller ones) — or none at all — cutting your costs and shortening your development time.
And, a 505(b)(2) product could receive fast-track approval, especially for products with limited changes from existing or approved drugs. Ideal candidates include:
Of course, the devil is in the details — and that's why this FDAnews webinar CD and transcript is led by an acknowledged expert. Kurt Karst is a Director with Hyman, Phelps & McNamara, and a widely respected legal authority and blogger on 505(b)(2) issues. He will teach you:
There's only one way to answer the question posed in this webinar's title — is a Section 505(b) (2) the right way for your company to go? Don’t miss this valuable webinar CD and transcript.
Kurt Karst, a Director with Hyman, Phelps & McNamara, is a widely respected legal authority and blogger on 505(b)(2) issues. Mr. Karst provides regulatory counseling to pharmaceutical manufacturers concerning Hatch-Waxman patent and exclusivity issues, myriad drug development issues, pediatric testing issues, and orphan drug issues.
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