JD Supra1h
FDA Finalizes Guidance on Communication of Unapproved Uses of Approved or Cleared Medical Products
On January 6, 2025, the FDA released final guidance for industry entitled “Communications From Firms to Health Care Providers Regarding ...
JD Supra1h
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On January 7, 2025, the Food and Drug Administration (FDA) made available a draft guidance for industry (GFI) titled “Considerations for the Use ...
Food Republic on MSN2d
The FDA Rules For Using A 'Healthy' Label On Foods
To be designated a healthy food under the FDA's guidelines, a product must adhere to strict limits on added sugars, saturated ...
The FDA Set Guidelines for 'Acceptable' Levels of Lead in Baby Food for the First Time — but Some Experts Say It's Not Enough
On Monday, the U.S. Food and Drug Administration (FDA) announced that, for the first time, it is setting guidelines for an ...
Ag Funder News13d
FDA draft guidance on labeling of plant-based foods ‘unfairly burdensome,’ says PBFA
The FDA does not favor commonly used descriptors such as ‘plant-based burger' on labels and suggests brands instead say ...
Healio7d
FDA releases draft guidance on pulse oximeter study recommendations
The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...
aha.org13d
FDA issues draft guidance on marketing submissions for AI-enabled medical devices
The Food and Drug Administration issued draft guidance Jan. 6 on marketing submissions and lifecycle management for ...
Drovers Cattle Network13d
FDA Releases Draft Guidance for Labeling Plant-Based Animal-Derived Foods
Comment period is open for the public to review the new draft guidelines for labeling plant-based alternative foods.
FDA issues draft guidance on developing weight loss drugs
New FDA draft guidance for drugmakers focuses on trial design for developing obesity treatments. Read more here.
BioSpace13d
FDA’s New AI Guidance Highlights Risks of Technology, Urges Early Sponsor Engagement
The FDA’s guidance on AI in drug development points to potentially life-threatening consequences of the technology, highlighting the importance of providing the regulator with detailed information ...
HealthDay on MSN12d
Health Advocates Are Unhappy with FDA Guidance on Lead Levels in Baby Food
The U.S. Food and Drug Association (FDA) released the first-ever guidelines for levels of lead in processed baby foods ...