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Jeffery, I was hoping for Annual Report based on the below guidance. What did you end up doing? Cindy Guidance for Industry CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports, March 2014, Appendix A: Examples of cmc postapproval manufacturing changes to be documented in ...

Hello, How are you guys filing drug substance assay method revisions that change from HPLC to UPLC? CBE-30? What is the rationale? Cindy ------------------------------ Cindy Lombardy Sr. Director, Regulatory Affairs B. Braun Medical Inc. Ringoes NJ United States --------------------------- ...

Interesting question.  Can a company submit an ANDA referencing its own NDA RLD? I did not think that was possible. If it was possible, wouldn't all brand companies do this to avoid the PDUFA annual product fees of ~$370K/product? ------------------------------ Cynthia Katsempris Director, Regulatory ...

Hello,  Does anyone know of any precedence for a company submitting an ANDA against your own NDA 505b2. Then, once the ANDA is approved you discontinue the NDA product, in essence then avoiding the PDUFA annual product fees. Is this possible? I did not think you could do this, but someone else has ...

What is the exact definition of discontinued in the Orange Book? Is it discontinued from marketing/selling, but product may still be unexpired in the marketplace? Or is it Is it discontinued from marketing/selling and all product in the marketplace is expired? ------------------------------ Cynthia ...