JD Supra19h
FDA Finalizes Guidance for Communications About Unapproved Uses to HCPs, Clarifying Multiple Standards
The U.S. Food and Drug Administration (FDA) has published final guidance on “Communications From Firms to Health Care Providers Regarding ...
JD Supra2d
FDA Issues Detailed Guidance for Biopharma Industry on What Information to Provide to FDA About Use of AI Models
On January 7, 2025, the Food and Drug Administration (FDA) made available a draft guidance for industry (GFI) titled “Considerations for the Use ...
STAT12d
In debate over obesity medications, FDA shifts toward importance of drugs in subtle ways
The changes reflect “a cultural shift” around obesity medications, said Diana Zuckerman, president of the nonprofit National ...
Motherly on MSN12d
The FDA sets new lead limits in baby food—but is it enough to protect babies?
The FDA’s new action levels set the following limits on lead content in processed foods for babies and young children: 1 0 ...
FDA ‘stuck to its corner’ with AI draft guidance, leaving plenty of questions unanswered
The first draft guidance provides an initial framework for how the agency will assess AI models in drug development, but the ...
Healio10d
FDA releases draft guidance on pulse oximeter study recommendations
The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...
FDA bans Red No. 3 dye found in many of your favorite snacks
Red No. 3, chemically known as erythrosine, was first introduced into foods in 1907. Companies subsequently added it to ...
Food7d
FDA removes Red No. 3 authorization, tees up mandatory reformulations
The FDA continues its regulation pronouncement streak, changing its authorization of Red No. 3 days ahead of the incoming ...
FDA issues final guidance on lead levels in baby food
The agency set levels as lead poison cases continue to pop up following a 2023 outbreak investigation into Wanabana ...
Healio13d
Diversity in pulse oximeter clearance summaries increases after 2013 FDA guidance
Following the FDA’s release of a guidance requesting more diversity in pulse oximeter testing, the number of clearance ...
Food Safety News3d
FDA announces new strategy to prevent contamination of fresh and frozen berries
The FDA has developed a new strategy to prevent the contamination of fresh and frozen berries with viruses such as hepatitis ...