The FDA has approved a new sunscreen ingredient called bemotrizinol for use in the United States, marking the first time in ...
The FDA released updated guidance on May 29, 2026, formalizing expectations for human factors information in medical device ...
The US Food and Drug Administration has updated three guidances to reflect revised timelines for responding to premarket approval (PMA), 510(k) and de novo applications under the latest Medical Device ...
The FDA has classified the Park St. Deli Macaroni & Cheese recall as Class II, affecting more than 500,000 packages sold at ...
A Boxed Warning was included in the prescribing information highlighting the risk of serious liver injury and acute liver failure. The Food and Drug Administration (FDA) has approved new safety ...
The FDA gave the coffee recall a Class II classification, meaning consumption could cause "temporary or medically reversible adverse health consequences" Select Keurig K-Cup Pods were recalled back in ...
FDA labeling now recommends DPYD variant testing before initiating capecitabine or 5-FU, except when immediate treatment is clinically necessary. Complete DPD deficiency markedly impairs 5-FU ...
Women considering hormone replacement therapy may have new options to discuss with their doctors after the U.S. Food and Drug Administration eased several major safety warnings on hormone products, ...
The United States Food and Drug Administration (FDA) issued revisions this month to its guidance documents "Clinical Decision Support Software" (CDS Guidance) and "General Wellness: Policy for Low ...
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