Medical Xpress
JANUARY 18, 2023
An investigational HIV vaccine regimen tested among men who have sex with men (MSM) and transgender people was safe but did not provide protection against HIV acquisition, an independent data and safety monitoring board (DSMB) has determined.
FDA Law Blog
JUNE 7, 2021
Subpart H) pathway in 2014, then issued it as final guidance in January 2019. 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. So how did we get here?
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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.
FDA Law Blog
SEPTEMBER 30, 2024
CMS did not finalize the price verification survey, which would have required manufacturers of 10 costly drugs selected annually to provide clinical information as well as information on production, distribution, research, and marketing costs, revenue and profit, and ex-U.S. pricing, among other things. See 42 U.S.C. 1396r-8(b)(3)(C)(iii).
Medical Xpress
JUNE 8, 2025
While many of these procedures provide critical care, we know they are acutely painful. Provided by The Conversation This article is republished from The Conversation under a Creative Commons license. The content is provided for information purposes only. During this time, they receive up to 16 painful procedures every day.
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.) FDA has estimated that there are more than 100,000 OTC drugs marketed through the monograph process, with 800 active ingredients for over 1,400 uses as of December 2019.
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