2015 Manufacturing Provider Vaccination 
FDA Law Blog
AUGUST 21, 2023
Recall that the funds provided under the Prescription Drug User Fee Acts (PDUFA) are not available to support the agency’s efforts related to monograph drugs.) Interestingly, the Plaintiffs alleged that this duty existed when the mother was pregnant in 2015 even though the studies relied upon in the litigation are from 2021.
FDA Law Blog
APRIL 7, 2025
Elanco is the manufacturer of recently approved Zenrelia (ilunocitinib tablets) (September 2024), which is indicated for control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. Further, information presented on the adverse reaction data was inconsistent with the PI.
FDA Law Blog
SEPTEMBER 14, 2021
The MFP would be established through negotiations between HHS and the manufacturer and would incorporate foreign pricing benchmarks, as further described below. In order to permit MFPs to be negotiated under Part D, the current prohibition on Medicare negotiating with manufacturers would be repealed.
Expert insights. Personalized for you.
40 
Let's personalize your content