A major update to federal women’s health preventive guidance will make it easier for women to get screened for cervical ...
The FDA’s emerging framework represents more than a regulatory update; it is a paradigm shift toward human-relevant, science-forward drug development. By reducing reliance on animal models and ...
The FDA released two final guidances and a new draft guidance today to increase the regulatory clarity around medical devices, including software as a medical device. The agency also announced the ...
The FDA's Center for Devices and Radiological Health has been busy over the last couple of months, releasing several draft and final guidances that affect the makers of apps and connected devices.
We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
Diamyd Medical has reached alignment with the U.S. Food and Drug Administration (FDA) to accelerate the primary efficacy readout in its ongoing pivotal ...
Industry analysis examines published SURMOUNT clinical trial data, evolving FDA compounding guidance, and telehealth access ...
The Food and Drug Administration (FDA) capped 2025 with a year-end report on Thursday, highlighting reforms, enforcement ...
Recent Trends and Patient Outcomes of Phase I Trials: A Single-Institution Experience in the Era of New Therapeutic Agents This study reviewed all industry-sponsored phase I clinical trial protocols ...
Similar to building a solid house that requires detailed preplanning, an FDA submission should ensure that all product teams be on the same page from day one of concept, according to Matthias Kaeser, ...
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