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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On January 7, 2025, the Food and Drug Administration (FDA) made available a draft guidance for industry (GFI) titled “Considerations for the Use ...
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FDA Releases Draft Guidance on Evaluating the Risk and Credibility of AI Used in Establishing Drug and Device Safety, Effectiveness, and Quality
This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how ...
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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 ...
FDA issues draft guidance on developing weight loss drugs
The U.S. FDA has released a new draft guidance for drugmakers to aid them in developing new treatments for obesity. The new ...
FDA bans Red No. 3. What has Robert F. Kennedy Jr. said about food dyes?
Manufacturers who use Red No. 3 in food will have until Jan. 15, 2027 to reformulate their products, while those who use the ...
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 ...
What foods will the FDA ban because of red dye? Here's what we know
The FDA has banned Red No. 3 dye which is in multiple foods, drinks, medications, and other products. Which ones have Red 3?
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FDA releases draft guidance on pulse oximeter study recommendations
The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...
Outgoing FDA chief flags online weight loss drug dangers
Current laws and regulations are not enough to protect Americans from the risks of compounded versions of popular weight loss ...
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FDA issues draft guidance on marketing submissions for AI-enabled medical devices
The Food and Drug Administration issued draft guidance Jan. 6 on marketing submissions and lifecycle management for ...
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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 ...
Red 3 Ban: Other Ingredients That Could Now Face FDA Scrutiny
Yellow No. 5 is commonly used in brightly colored soda and candy, often to make them appear fresher and more appetizing.