GPhA Waxman/Hatch Plan Would Use Bonds To Protect 180-Day Exclusivity
The Generic Pharmaceutical Association is proposing to change the Waxman/Hatch patent challenge process to use bonds posted by brand name companies as a substitute for market exclusivity to provide an incentive for generic companies.
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It is unclear in a revised staff manual guide whether Commissioner's National Priority Voucher program approval “recommendations” from the drug and biologic center directors will be advisory or decisional, experts told the Pink Sheet.
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Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
