The US Food and Drug Administration on Thursday finalized guidance on its expectations for applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) in submitting field ...
The US Food and Drug Administration (FDA) on Wednesday issued draft guidance providing the agency’s current thinking on the requirements for submitting field alert reports (FARs) by applicants of new ...
FDA drug alerts in infectious diseases, including new drug approvals, safety warnings, recalls, and changes in indications.
US regulators issued a new alert about liver injury, including fatal cases, linked to avacopan (Tavneos), a medicine for a rare autoimmune disease that the agency had already asked to be voluntarily ...
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