JD Supra2h
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On January 7, 2025, the Food and Drug Administration (FDA) made available a draft guidance for industry (GFI) titled “Considerations for the Use ...
JD Supra2h
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 ...
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FDA draft guidance on labeling of plant-based foods ‘unfairly burdensome,’ says PBFA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 ...
Hosted on MSN13d
FDA kicks off new year with draft guidance on skin biopsies in trials
The US Food and Drug Administration has issued guidance urging sponsors and trial sites to consider the necessity of the ...
Food Safety News18h
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 ...
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FDA releases draft guidance on pulse oximeter study recommendations
The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...
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FDA Releases Draft Guidance for Labeling Plant-Based Animal-Derived Foods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.
Yahoo Finance12d
FDA finalizes guidance on device shortage reporting rules
The Food and Drug Administration has finalized guidance on manufacturers notifying the agency of changes that could likely disrupt the supply of medical devices. Officials created the guidance to ...
FDA issues draft guidance on developing weight loss drugs
New FDA draft guidance for drugmakers focuses on trial design for developing obesity treatments.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.
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 ...
Healio10d
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 ...