Pharma, biopharma, and medical device makers should watch out for these perennial problems, which include inadequate ...

The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to ...

The U.S. Food and Drug Administration (“FDA”), in partnership with the Department of Justice (“DOJ”), pursued significant and, in some ...

Viral social media posts claim that one of the orders revoked was one that lowered prescription drug costs for people on ...

FDA issues warning to Hologic, citing manufacturing and safety violations for BioZorb devices. Patient safety risks and reporting failures highlighted ...

The FDA bans Red No. 3, a synthetic food dye linked to cancer in rats, giving manufacturers until 2027 to reformulate. This decision reflects growing concerns over synthetic additives' safety. Listen ...

The Food and Drug Administration this week banned the use of Red Dye No. 3 in foods, meeting requirements of the 1960 Delaney Clause of the Food, Drug and Cosmetic Act. The action comes after ...

Found in everything from candies to cosmetics, it’s hard to ignore its bright hue. However, recent developments have sparked concerns about its safety, leading the FDA to take long-overdue action. Let ...

Companies say they are working to update their products to comply with the Food and Drug Administration's decision Wednesday to ban the artificial food dye Red 3, after the agency said it was ...

Red Dye No. 3, or erythrosine, is a synthetic red food dye once popular in candies and cakes. The ... [+] FDA bans Red Dye No. 3 under the Delaney Clause, citing cancer risks observed in lab ...

Hologic stopped manufacturing the device after reports of serious adverse events in patients who had the markers implanted in breast tissue.