Thought Leadership

Multisponsor REMS

The pharmaceutical industry has entered an era of change, during which product development will focus on niche patient groups; generics and biosimilars will fill the space vacated by patent-expired blockbuster drugs; and FDA will likely exhibit more regulatory authority for drug safety and use. This brief from PwC addresses the following.

  • How REMS evolve with the changing pharmaceutical market
  • Multiple sponsors
  • Communication strategies
  • Formalized decision making process
  • Cost-sharing model
Multisponsor REMS

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