The U.S. Food and Drug Administration issued a draft guidance that, when finalized, will outline the agency’s approach to evaluating the public health importance of food allergens that are not one of the major nine food allergens identified by law in the United States (non-listed food allergens).
The U.S. Food and Drug Administration issued a new draft guidance to industry for developing plans to enroll more participants from underrepresented racial and ethnic populations in the U.S. into clinical trials – expanding on the agency’s previous guidances for industry to improve clinical trial diversity.
Lilly and Roche expressed their criticism of the draft guidance from the U.S. Centers for Medicare & Medicaid Services (CMS) for Biogen’s Alzheimer’s drug Aduhelm (aducanumab).
Manufacturers and their communications agencies see great opportunities in a new draft guidance from FDA, but the fear of warning letters still shadows the industry.
The U.S. health regulator issued draft guidance, recommending ways to communicate promotional materials and additional information that is not on the label of medical products.