The FDA Modernization Act of 1997 established the Fast Track designation to expedite developing and reviewing new drugs designed to fill unmet medical needs and treat serious conditions.

The Food and Drug Administration on Thursday proposed ending the use of a common ingredient found in many popular over-the-counter cold and allergy medications. The agency said an extensive ...

The investigation is in its early stages, and 33 patients have been discovered. The Food and Drug Administration has not released any patient information, such as where the patients live or their ...

The U.S. Food and Drug Administration has published the 2022 Food Code Supplement. The Supplement updates the 2022 Food Code with recommendations from regulatory officials, industry, academia ...

The Food and Drug Administration has announced a recall for thousands of bottles of the antidepressant duloxetine, sold under brand names like Cymbalta, due to the presence of a chemical that can ...

The U.S. Food and Drug Association (FDA) has announced more brands of ground cinnamon that contain elevated levels of lead and may be unsafe to consume. The specific products are sold at chain ...

The Food and Drug Administration (FDA) is proposing to officially remove a popular ingredient in many cold and allergy medications – oral phenylephrine. The active ingredient is used in over ...

Opens in a new tab or window Share on LinkedIn. Opens in a new tab or window The FDA announced on Thursday a proposed order to remove oral phenylephrine as an active ingredient in over-the-counter ...

The Food and Drug Administration announced a Class II recall for more than 7,000 bottles of an antidepressant due to a chemical. The recall was initiated earlier this month on Oct. 10. Duloxetine ...

Just as cold and flu season arrives, the Food and Drug Administration proposes pulling many decongestants from store shelves. The reason? An administration review found oral phenylephrine — a ...