FDA drug alerts in infectious diseases, including new drug approvals, safety warnings, recalls, and changes in indications.
The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.
As discussed previously (“New FDA Guidance Allows Biosimilar Applicants to Use Data From Outside the U.S. To Accelerate Their Approval in the ...
FDA expands Dupixent approval for children aged 2 to 11 years with chronic spontaneous urticaria symptomatic despite H1 antihistamine use.
The U.S. Food and Drug Administration has asked Eli Lilly for more data on liver injury linked to its newly approved obesity pill, according to a letter posted on the health regulator's website. The ...
The US Food and Drug Administration (FDA) has released draft guidance aimed at assisting pharmaceutical manufacturers in transitioning from animal studies to non-animal alternatives for drug ...
The Food and Drug Administration is warning consumers about 19 types of cookware that may contain lead, increasing the risk that the toxic metal could wind up in people's food. Consumers should check ...
Health authorities in the U.S. are continuing their move away from animal testing in drug development, with the FDA signaling an openness to new approaches that haven’t been validated and the National ...
The FDA's draft guidance could streamline biosimilar approval by reducing the need for comparative efficacy studies, emphasizing analytical assessments instead. This approach may lower development ...
In a new draft guidance, the US Food and Drug Administration (FDA) has provided details on the clinical investigation requirements that sponsors of new drugs must meet to obtain three years of ...
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