Analysis Says Prevnar 13 In Adults Cost-Effective, But Asks Same Questions As ACIP
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New post-marketing commitment will look at conjugate pneumonia vaccine when given in patients 50 and older who have already received Merck’s polysaccharide vaccine.
Agency officials determining needs using existing budgets before requesting more funds and will engage with tech investors for design advice.
With the pre-GDUFA backlog largely acted upon, the FDA expects ANDA approvals to decrease, but supplement actions to increase in FY 2020 and FY 2021.