Due to concerns about these chemicals’ links to cancer risks, the FDA under the Biden administration considered proposing a ban on these ingredients in certain cosmetic products such as chemical ...

A PCCP allows manufacturers to include a detailed plan for future device changes within a 510(k), PMA, or De Novo submission. Once approved by the FDA, the PCCP allows manufacturers to implement ...

FDA encourages manufacturers to consider whether a Predetermined Change Control Plan (PCCP) might also be appropriate in the submission and references the Agency’s final guidance, issued last ...

The new guidance follows final guidance the FDA issued last month on pre-determined change control plans (PCCP), a framework for changes to devices after they are on the market. Currently ...

FDA's new "nutrition info box" focuses on telling people whether levels of saturated fat, sodium and added sugar are "high" or "medium" or "low" as well as the percentage for each serving.