Individual Manufacturing Patient-Centered Patients 
Annals of Family Medicine
NOVEMBER 20, 2024
Context: FITs are an accepted method of colorectal cancer (CRC) screening and patients’ preferences and difficulties are unknown. Setting: 3 academic medical centers. Population Studied: 2148 individuals aged 50 to 85 years scheduled for screening or surveillance colonoscopy. Multiple FITs are available in the U.S.
Physician's Weekly
JULY 1, 2025
The conference highlighted the latest advances in diabetes research and improving patient care, with presentations focusing on treatment recommendations and advances in management technology. ” The study was funded by MannKind, the manufacturer of Afrezza. As part of the INHALE-1 study, Michael J. Haller, M.D., 1956-LB Felicia L.
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FDA Law
FEBRUARY 28, 2022
Bauer, Senior Regulatory Drug Expert — Our readers probably know that we value and advocate for patient engagement as an essential component in the development of medical products (see our firm’s commitment here ).
FDA Law
NOVEMBER 1, 2023
Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.
FDA Law
NOVEMBER 6, 2022
In its petition filed earlier this month, Pfizer challenges HHS’s interpretation of the AKS as “staggeringly overbroad,” contrary to the congressional intent behind the AKS, and a threat to “almost any activity that facilitates patient access to federally funded healthcare.” Background.
FDA Law
OCTOBER 9, 2023
The ACA sets an annual cap on the amount that insurers can require insured individuals to pay out of pocket for their medical expenses. Once an individual reaches this annual cap, the insurer is solely responsible for covering the individual’s remaining medical expenses that year.
FDA Law
OCTOBER 14, 2024
California Stem Cell Treatment Center, Inc., At the clinics, Defendants offer treatments that consist of extracting fat tissue from patients and, through a multi-step process, turning that tissue into a liquefied mixture of stem cells, other cells and cell debris known as Stromal Vascular Fraction (SVF). By Steven J.
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