The Medical Futurist

JUNE 17, 2025

For dentists, it’s transforming diagnosis, decision-making, and treatment planning. Researchers in 2019 developed a machine learning method to accurately quantify immune cells in the vicinity of oral cancer cells. This image is then relayed to a machine that manufactures the crown right in the office.

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FDA Law Blog

OCTOBER 14, 2024

Regulatory Background FDA regulates and generally requires premarket approval of all new drugs, which are defined as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease,” or “intended to affect the structure or any function of the body.” 588, 566 (2019)). 21 U.S.C. § Robbins , 519 U.S.

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Clinic Patient-Centered Asthma Patients 59

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. Remarkably, manufacturers may not dispute a CMS notification.

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FDA Law Blog

JUNE 2, 2023

Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers. Price Transparency Surveys The MDRP statute requires manufacturers to submit only three prices: average manufacturer price (AMP), best price, and nominal prices.

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