Ansis Helmanis is a former FDA official and founder of RegLink Associates.
Harvey Bale, Jr., MD, former Director-General, IFPMA
Jane Henney, MD, Former FDA Commissioner
The strict regulatory divide between market authorization and price reimbursement iscrumbling in the US. Is industry prepared to adapt or challenge?
Obligations to fund and support costly studies can extend beyond the period of market exclusivity, giving generics competitors an advantage.
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