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. However, the FDA guidance goes on to say in some cases, additional context is needed by specifically inserting a sentence in the indications statement that: no clinical benefit has been established.
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Physician's Weekly
JUNE 21, 2025
Preventive measures such as timely vaccination against hepatitis viruses also remain crucial in reducing the burden and complications of liver disease. The primary composite outcome was all-cause mortality or clinically significant rebleeding within 1 year. SD 5.0]).
Medical Xpress
JUNE 8, 2025
Long-term effects of pain in early life We collected data on the number of procedures, clinical exposures and sucrose doses from three NICUs across Canada. But as the findings from our Canadian study show, we urgently need research to improve long-term health outcomes for children born prematurely.
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).
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.
Tiny Physician
OCTOBER 17, 2021
On the brighter side, daily case count drastically decreased and vaccination drive is happening at top speed. Almost 1 billion doses of vaccine have been administered so far and the situation is currently under control. However, there is no clinical trial on its effect on COVID 19 infection or its complications.
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