FDA Safety Labeling Change Guidance Seeks To Ease Class Confusion

FDA’s final guidance on safety-related labeling changes under the FDA Amendments Act responds to industry calls for more clarity on how such revisions will be handled across a class of products, including those instances when one or more sponsors disagrees with the proposed changes for a group of products.

However, the guidance released July 30 does little to further clarify for industry what is meant by “new safety information”...