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FDA inspectors have oversight over nearly 300,000 food manufacturing or handling facilities, more than half of which are outside the U.S. Food testing — for contaminants like lead, bacteria ...

The agency updates and modifies the alerts as needed. Recent modifications to FDA’s import alerts, as posted by the agency, are listed below. Click here to go to the FDA page with links to ...

Dr. Marty Makary — a surgeon, author and researcher — lauded the FDA’s “gold-standard science” in testimony before the Senate’s health committee, which will vote on whether to advance ...

At that time, no allergic reactions related to recall were reported. On Feb. 13, the FDA classified the recall of the pancake and waffle mix to the highest level, a Class I. The FDA defines a ...

Per Reuters, 20 people who worked in the FDA’s office of neurological and physical medicine devices got axed as part of a broader effort being carried out by DOGE to cut down the federal workforce.

In the AAL, the FDA determined this is a minor amendment, meets the criteria for priority review, and assigned an approval goal date of June 4. As announced on March 3, PharmaTher provided its ...

Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration (FDA) has approved TNKase ® (tenecteplase), a thrombolytic or clot-dissolving agent, for the ...

Among the challenges: During the final month of the Biden administration, the FDA proposed a front-of-package food labeling rule. The proposed rule would have required certain food manufacturers ...

The senators also drew attention to the user fee system at the FDA, under which Congress authorizes the agency to collect fees from industry that submit applications for review. The user fee ...

In a regulatory filing, DexCom (DXCM) disclosed that on March 4, the company received a warning letter from the U.S. FDA following inspections of the company’s facilities in San Diego ...

The U.S. Food and Drug Administration has made an update to its MadeGood granola bar recall. The popular granola bars, sold on Amazon and in stores like Target, Whole Foods, Wegmans, CVS, among ...