The Supreme Court agreed to review a controversy over so-called skinny labels for medicines, a decision that will be closely ...
The federal government re-ignited a controversial proposal to give generic drug makers the power to unilaterally update product labels to reflect new safety information, a proposal that drew criticism ...
Medications once used to treat illness are increasingly being taken for prevention. Experts explain what’s behind the ...
On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the “Guidance”) ...
America is in the midst of a pharmacy crisis, and the Food and Drug Administration could make it much worse. Hundreds of ...
Last week, the U.S. Food and Drug Administration (FDA) published the proposed rule “Medication Guides: Patient Medication Information,” which would significantly change the agency’s prescription drug ...
The Skinny Labels, Big Savings Act was introduced on January 9 in an effort to provide “a statutory safe harbor from patent ...
Project Renewal updates older oncology drug labels to ensure clinical relevance and scientific accuracy, involving external experts and early-career scientists. Fludarabine phosphate's updated label ...
Physicians are increasingly prescribing medications off-label to children, with one-fifth of all pediatric physician visits resulting in off-label prescriptions, according to a study published in ...
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