of course, is not unique to labs with LDTs; kit manufacturers also need to obtain those insights well before they begin studies.) The process for gaining this alignment is through the pre-
Some predict apps will allow physicians to diagnose patients with potentially life-threatening conditions outside of traditional health care settings and help individuals manage their health and wellness and gain access to useful information whenever and wherever they need it. Full Text ...
Medical law and pharmacology is already highly complex, and nowhere is that more than within the FDA. Experts with Former FDA all have experience working with FDA law, regulations and FDA lawyers as part of their former jobs with the FDA. For litigations it’s important to have the inside ...
As practicing physicians, approval by the U.S. Food and Drug Administration (FDA) reassures us that the treatments we prescribe our patients have been rigorously vetted as effective and safe. For a growing number of drugs, however, FDA approval comes with lingering uncertainty of their benefit....
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CEO Stephen Kramer called Exxua’s approval an “important milestone in the treatment of MDD,” adding that the drug can provide patients and physicians with “a new option” to manage depression and improve quality of life. To support Exxua’s novel activity, Fabre-Kramer backed its regul...
Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) is the first-ever approved therapy for metabolic dysfunction-associated steatohepatitis—a decision experts say could signal a sea change in treatment of the disease.
U.S. physicians are captive audience for pharmaceutical advertising. This applies to other countries as well. They learn which drugs to prescribe. They do not learn of alternative procedures and perhaps better ways of caring for their ill patients."...
Administration (FDA) standardizes the information patients receive from their mammogram providers about their breast density. It also requires language prompting patients—particularly those with dense breasts—to talk in greater depth with their physicians about their results and whether additional imaging ...