The US Food and Drug Administration (FDA) has released a new draft guidance describing what should and should not be included in the Drug Interactions (DIs) section for human prescription drug and ...
The US Food and Drug Administration (FDA) has issued two draft guidance documents aimed at improving the consistency of labeling for both over-the-counter (OTC) and prescription drugs. One of the ...
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 ...
A common drug combo for Parkinson’s disease will require a new FDA warning after the agency flagged 14 cases of seizures in patients using the medications. The agency is mandating (PDF) that ...
The FDA is seeking public input on drug repurposing efforts aimed at expanding treatment options for diseases tied to unmet medical needs. The agency said identifying new uses for FDA-approved drugs ...
The FDA has added new warnings to GLP-1 medications such as Ozempic, Wegovy, and Mounjaro about pulmonary aspiration risk ...
A label begins with highlights, a succinct, half-page summary of the information that health care practitioners most commonly refer to and view as most important (Figure 2). [4] This section provides ...
FDA’s final SIUU guidance loosens some off-label communication rules, but drugmakers still face strict compliance demands to ...
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