FDA Contests Court Intervention On Plan B As Teva Argues For Exclusivity
In CRR’s lawsuit, FDA and Teva argue that the firm’s potential for OTC market exclusivity for Plan B One-Step should be protected. But while Teva is open to judicial intervention on whether to allow universal OTC sales, FDA says precedent supports judicial deference to agency scientific decisions.
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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.
