IDStewardship
APRIL 14, 2024
Candidate 2025 Mentored by: Christina G. These advancements are evidenced by the two FDA-approved FMT products available for rCDI prevention: Rebyota (Fecal Microbiota, Live-jslm) and Vowst (Fecal Microbiota Spores, Live-brpk). Rebyota, a solution delivered via enema, was the first FMT product to be FDA-approved. Gut Microbes.
The FDA Law Blog
MARCH 21, 2024
Now in the second year of implementation, companies have started noticing the consequences as FDA implements the new requirements and develops regulations and guidance. The MoCRA rollout, though, does not preclude that FDA may practice some regulation by enforcement if it deems such action necessary.
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pharmaphorum
SEPTEMBER 29, 2022
A digital patient monitoring tool developed by UK company CyberLiver has been given a breakthrough designation by the FDA for out-of-hospital management of patients with cirrhosis at risk of complications. The post Digital tool cuts hospital readmissions in cirrhosis patients appeared first on.
Omnicell
JANUARY 10, 2023
This trend is likely to continue with specialty medications expected to account for 65 percent of drug spending by 2025. Namely, there are currently more than 400 new cell and gene therapies under development, and 60 percent of the new molecular entities awaiting FDA approval are specialty pharmaceuticals.
Pharmaceutical Technology
JANUARY 20, 2023
The CEO illustrated his point, by discussing that in June, the Center for Biologics Evaluation and Research (CBER), at the FDA, requested new vaccines for the BA.5 Construction will start in early 2023, and the UK plans to produce the first mRNA vaccine there in 2025. 5 Omicron variant.
The FDA Law Blog
JUNE 7, 2023
the Medicaid Drug Rebate Agreement and the Medicare Part D Coverage Gap Discount Agreement or the agreement under the successor Part D discount program that begins in 2025), Merck characterizes that as a coercive penalty for the refusal to forfeit its First and Fifth amendment rights.
Pharmaceutical Technology
JUNE 19, 2023
Planning, planning, planning, using validated shippers, ensuring robust packaging processes, and communicating product specifications to ensure as many variables as possible are accounted for is the key to success,” he continues. “A
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