Pharmaceutical Regulation, Compliance & Policy, Part 3: A Close Look at Generic Drugs
· 46 min · S1 E24
Episode Pharmaceutical Regulation, Compliance & Policy, Part 3: A Close Look at Generic Drugs
In this third part of our series in collaboration with Hyman, Phelps & McNamara (HPM), Wayne chats with Sara Koblitz, Director at HPM; Kurt Karst, Director at HPM; and Karin Hessler, General Counsel at the Association for Accessible Medicines. Together, they discuss the biggest hurdles that the generic industry needs to overcome in today's regulatory environment; the effect of pressure on industry to continue lowering drug prices; how the Hatch-Waxman Act has played out over the past 40 years; how the act can be used to address drug shortages; incentives for companies to develop follow-on products to avoid shortages; how tariffs are impacting generic drug manufacturing overseas; and much more.
This episode and the rest of our series do not include the usual Headlines and Resources Links segments.
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Music by Dvir Silver from Pixabay.
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