On December 17, 2024, the Department of Health & Human Services, Office of Inspector General (HHS-OIG) issued its second favorable advisory opinion involving an arrangement in which a drug ...
The latest efforts by the U.S. Food and Drug Administration (FDA) to modernize regulation of the 510(k) program come in the form of a trio of new draft guidance documents regarding its Premarket ...
FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" is probably the most used ...
This publication is available from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www ...
The Centers for Disease Control and Prevention announced Friday that it would wind down much of its remaining guidance specifically targeted at COVID-19, including an official end to a pandemic-era ...
In most cases, a diagnosis of NF1 is made through a clinical diagnosis based on the presence of two or more of the six NIH diagnostic criteria for the disorder. However, sometimes a diagnosis of NF1 ...
New guidance, and the promise of a new rule, are expected to cut off funding to Planned Parenthood starting in 2027. The Trump administration on Friday took the first step toward reviving and ...
Suggested Citation: "5 PFAS Testing and Concentrations to Inform Clinical Care of Exposed Patients." National Academies of Sciences, Engineering, and Medicine. 2022. Guidance on PFAS Exposure, Testing ...