2020 Provider Utilities Vaccination 
FDA Law Blog
JUNE 7, 2021
It is noteworthy that this sentence that no clinical benefit has been established was deemed by FDA as unnecessary for Aduhelm to provide additional context beyond that the approval is based on reduction in amyloid beta plaques. be “reasonably likely to predict” ultimate clinical benefit). Yesterday’s approval of Aduhelm helped answer that.
BMJ
MAY 10, 2022
Introductory article to İkİIşik H, Sezerol MA, Taşçı Y, et alCOVID-19 vaccine hesitancy and related factors among primary healthcare workers in a district of Istanbul: a cross-sectional study from TurkeyFamily Medicine and Community Health 2022;10:e001430. 29% (n=86) of the participants were undecided about getting vaccinated.
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FDA Law Blog
JUNE 2, 2023
For 10 high-cost single source covered outpatient drugs selected annually by CMS, manufacturers would be required to respond to a so-called “price verification survey” by providing not only clinical and utilization information about the drug, but also costs of production, distribution, research, and marketing; revenue and profit; and ex-U.S.
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.) Liability is precisely why the vaccine market shrunk so significantly in the 1980s, going from 26 manufacturers to 4, after lawsuits claiming $3.5
FDA Law Blog
AUGUST 14, 2022
The negotiations will result in a Maximum Fair Price (“MFP”) that the manufacturer must make available to providers furnishing the drug under Medicare Part B or pharmacies dispensing the drug under Part D. The same will be required under state Medicaid and CHIP programs by October 1, 2023.
FDA Law Blog
SEPTEMBER 14, 2021
A manufacturer that failed to provide access to the MFP would be subject to a civil monetary penalty of ten times the excessive price charged. The Part B rebate would exclude vaccines as well. The AIM price is the volume-weighted average price of the drug in Australia, Canada, France, Germany, Japan, and the U.K.
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