The U.S. Food and Drug Administration (FDA) is warning U.S. consumers not to use the emergency birth control medicine labeled as Evital. These products may be counterfeit versions of the “morning after pill” and may not be safe or effective in preventing...
The U.S. Food and Drug Administration (FDA) is warning U.S. consumers not to use the emergency birth control medicine labeled as Evital. These products may be counterfeit versions of the “morning after pill” and may not be safe or effective in preventing...
The U.S. Food and Drug Administration today issued draft guidance that clarifies when changes or modifications to a previously cleared 510(k) device require a new premarket submission.
The FDA is taking steps to protect the public following the identification of Salmonella Agona in Agromod Produce, Inc.’s supply of fresh papayas. The FDA is advising consumers not to eat papayas from Agromod Produce, Inc. The company is voluntarily recalling the...
A U.S. Food and Drug Administration report from its Center for Drug Evaluation and Research (CDER), available today in the Federal Register, identifies the current regulatory science needs that will guide CDER’s strategic planning of internal research initiatives and...
The U.S. Food and Drug Administration today approved the blood-thinning drug Brilinta (ticagrelor) to reduce cardiovascular death and heart attack in patients with acute coronary syndromes (ACS).
