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Quality Assurance & Food Safety17h

FDA, Stop Foodborne Illness Food Safety Culture Webinar Series Returns

Collaborating on Food Safety Culture” resumes Sept. 3, following a nine-month hiatus, with the webinar “How to Turn a Problem into an Opportunity.” ...

Sarepta shares fall 37% as FDA questions future of key gene therapy

Shares of Sarepta Therapeutics fell close to 37% on Friday after reports emerged that the US Food and Drug Administration is ...
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FDA Regulatory Updates for Summer 2025: Food, Supplements, and Cosmetics

Recent actions by the Food and Drug Administration (FDA or Agency) reflect a sharpened scrutiny in areas where public health and safety may ...
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FDA issues letter to industry on recall communications for infant and baby foods

On July 9, 2025, the U.S. Food and Drug Administration (FDA) issued a letter from Commissioner for Human Foods Martin Makary and Deputy ...

FDA Lifts Pause On Kezar's Liver Drug Trial—Next Stop Lupus Study

Kezar Life Sciences' zetomipzomib trial in autoimmune hepatitis resumes as FDA lifts partial hold following a favorable safety review.
Food Safety News6d

FDA wants industry to suggest how to better use recalls for food safety

The Food and Drug Administration is calling on industry to provide input on how to better institute recalls, particularly for food for infants. In a ...

FDA Commissioner: 100 Days of Change—Modernizing the FDA for a Healthier America | Opinion

The Food and Drug Administration (FDA) can maintain its high bar for safety and efficacy, and also cut the waste and ...
Quality Assurance & Food Safety10d

FDA Calls for Streamlined Product Recall Communications to Protect Food for Infants and Children

The U.S. Food and Drug Administration is calling for increased attention to product recall communications from industry ...
Fierce Pharma11d

‘Weak’ evidence and an ‘unpleasant’ odor: FDA sheds light on drug refusal process

When the FDA unexpectedly uploaded around 200 drug rejection letters this week, the regulator provided an in-depth view | ...
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FDA revises labeling on extended-release stimulants for ADHD to include ...

FDA requires labeling about weight loss risk in patients younger than 6 years taking extended-release stimulants for ADHD. FDA. Drug Safety Communication. June 30, 2025.
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FDA investigates patient deaths after treatment with Sarepta's Duchenne ...

In its Tuesday safety communication, the FDA’s language set the parameter for the investigation to focus on the drug’s use in non-ambulatory patients.