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In this fourth and final part of our series in collaboration with Hyman, Phelps & McNamara (HPM), Wayne chats with Michelle Butler, Director at HPM; Charles Raver, Associate at HPM; and Josephine Torrente, Director at HPM. Together, they discuss potential avenues to resolve a disagreement informally; how the formal dispute resolution (FDR) process works; why companies would engage in the FDR process and what constitutes a win; common misconceptions about the FDR process; what changes may be coming to the FDR process; and much more.

This episode and the rest of our series do not include the usual Headlines and Resources Links segments.

To subscribe or find out more information about our podcast, visit FDAWatch.net.

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Music by Dvir Silver from Pixabay.

Pharmaceutical Regulation, Compliance & Policy, Part 4: Dispute Resolution for Drugs and Biological Products