The Food and Drug Administration today released two guidance documents; one related to low-risk wellness products (including ...

New guidelines for healthy eating say Americans should eat more whole foods and protein, fewer highly processed foods and ...

The FDA’s new draft guidance on Bayesian methodology signals a shift toward more flexible, data-driven clinical trial designs, enabling sponsors to use prior data and adaptive approaches to improve ...

这个发现让我既意外又释然。意外的是，被行业奉为“红线”的CSV验证，竟从未成为FDA的直接处罚靶点；释然的是，这恰好印证了我多年的判断：CSV更多是行业内人为制造的焦虑，脱离这种束缚，才能真正发挥电子实验记录本（ELN）的价值——而这，恰恰契合FDA ...

FDA staffers and outside experts worry the program runs afoul of legal, ethical and scientific standards used to review new ...

An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...

NEW YORK — The 2025-2030 version of the Dietary Guidelines for Americans should be released this month and will emphasize whole foods, said Kyle Diamantas, deputy commissioner for human foods at the ...

FDA’s recently unveiled 2025 Human Foods Program guidance agenda offers a detailed view of the agency’s priorities for the year ahead. The document is non-binding, but provides critical insight into ...

FDA proposes framework clinical trial designs to guide Bayesian methods, improving efficiency in drug development for rare and pediatric conditions.

The Food and Drug Administration released updated safety standards Tuesday for makers of COVID-19 vaccines despite efforts by the White House to block them, clearing the way for requirements that are ...

Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device ...

Qualifying for *** COVID-19 vaccine really depends on your age, health, and insurance coverage. And now most people don't meet the guidelines. On Wednesday, the Food and Drug Administration approved ...