FDA prioritizes guidance on lab developed tests in 2025 plan
The Center for Devices and Radiological Health intends to develop final guidance on its enforcement discretion policy ...
CBS News on MSN12 天
FDA's promised guidelines on pulse oximeters unlikely to end decades of racial bias
For decades, widely used pulse oximeters have underestimated the oxygen needs of darker-skinned patients. Will the FDA's new ...
Her breast density camouflaged her cancer. She says new FDA regulations are "a gift."
"If I have dense breast tissue, am I more prone to get cancer?" CBS News New York's Kristine Johnson asked. "The answer is, ...
The Pharma Letter2 天
FDA guidance for reconsideration at the division level under GDUFA
The US Food and Drug Administration (FDA) yesterday published the guidance for industry, “Requests for Reconsideration at the ...
Food Safety News17 小时
FDA updates food import alerts for unapproved drugs, heavy metals and more
The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from foreign countries.
News Medical on MSN2 天
FDA strengthens AI regulation to ensure patient safety and innovation in healthcare
The FDA is adapting regulations to manage AI’s rapid development in healthcare, focusing on patient safety and the life cycle ...
FoodBusinessNews3 天
Should FDA’s GRAS process be updated?
Broad Leib, a clinical professor of law at Harvard Law School, said the FDA should require manufacturers share all new GRAS ...
JD Supra9 天
Final FDA electronic systems guidance offers greater compliance flexibility
The U.S. Food and Drug Administration (FDA) finalized its revised guidance summarizing how it intends regulate the use of electronic systems, ...
Ex-FDA food expert reveals worst cereal in America with link to cancer
An ex-FDA employee has revealed what he claims is the most harmful breakfast cereal on the US market.
sciencex2 天
NIH and FDA leaders call for innovation in development of smoking cessation treatments
Science X is a network of high quality websites with most complete and comprehensive daily coverage of the full sweep of ...
instrument1 天
【HANSON】使用RDS Phoenix自动化扩散站进行IVRT方法测定Eucrisa局部用软膏的
Eucrisa®是辉瑞旗下 Anacor Pharmaceuticals Inc. 拥有的一款专禾刂参考上市药物（RLD）产品，其软膏含有2% ...
信念医药基因治疗药物获得美国FDA儿科罕见病资格认定｜北极光·Family
专注前沿基因治疗领域的全球化的创新型企业信念医药集团（Belief BioMed，BBM，下称“信念医药”）宣布： ...