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Every Claim You Make, Every Step You Take…CVM Will Be Watching You

FDA Law Blog

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.

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A Review of H5N1

Alabama Academy of Family Physicians

Since 2016, HPAI H5N1 has been detected in wild birds in the United States during screening efforts by wildlife authorities. Also, CDC has provided a candidate vaccine virus to manufacturers for rapid production if needed. Several commercial laboratories are providing this service including Quest, LabCorp, ARUP and Mayo.

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Drug Pricing Reform Gathers Steam (Part 2)

FDA Law Blog

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permit MFPs to be negotiated under Part D, the current prohibition on Medicare negotiating with manufacturers would be repealed.