FDA AmVaz Review Could Take Two Months
FDA's re-evaluation of the review for Dr. Reddy's AmVaz (amlodipine maleate) should be completed within two months, the agency says in a Feb. 18 court filing
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Last Minute Course Shifts, Focus On Unknowns: What Sponsors Should Learn From Prasad’s Interventions
The once and current CBER director’s justification for his COVID-19 decision stands as a warning of the uncertainty sponsors, particularly those in the vaccine space, may now face at FDA.
Pink Sheet Drug Review Profile feature listing FDA staff who conducted the reviews of Novavax and Moderna's post-pandemic COVID-19 vaccines
Business Group on Health annual employer survey highlights fast-growing Rx costs, led by the GLP-1 drugs, and payer strategies for controlling them. Policy prescriptions are unclear, though, since employers are loath to leave PBMs and nervous about pending changes to Medicare and Medicaid.