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Food and Drug Administration (FDA) Life Sciences Drug Safety

Troutman Pepper Locke

A Model’s Credibility Is in the Details: FDA Draft Guidance on the Use of AI Models in Drug and Biological Product Development

Troutman Pepper Locke on

In January, the U.S. Food and Drug Administration (FDA) issued its first guidance on the use of artificial intelligence (AI) models in drug development and in regulatory submissions titled, “Considerations for the Use of...more

K&L Gates LLP

FDA Revokes Authorization for the Use of Red Dye No. 3 in Food and Ingestible Drugs

K&L Gates LLP on

On 15 January 2025, the US Food and Drug Administration (FDA) announced that it will revoke the color additive authorization for use of FD&C Red No. 3 in food (including dietary supplements) and ingestible drugs. This ban...more

Ropes & Gray LLP

FDA Issues Draft Guidance Describing When a Confirmatory Trial of a Drug Seeking Accelerated Approval Is “Underway”

Ropes & Gray LLP on

In recent years, Congress and the U.S. Food and Drug Administration (“FDA”) have sought to reform the accelerated approval process, an expedited development and approval pathway for drugs that provide meaningful therapeutic...more

Akin Gump Strauss Hauer & Feld LLP

In Waning Days of the Current Administration, FDA Announces Red No. 3 Ban

On January 15, 2025, FDA announced an order revoking the listings providing for the use of the color additive FD&C Red No. 3 in both foods (including dietary supplements) and ingested drugs. The order is in response to a 2022...more

Foley Hoag LLP

Caught in FDA’s Crosshairs: Delta-8 THC Products Invite Increased Scrutiny

Foley Hoag LLP on

The Food and Drug Administration (FDA) issued a consumer alert related to Delta-8 tetrahydrocannabinol (Delta-8 THC), following a recent increase in adverse event reports to FDA and poison control centers. Although Delta-8...more

Mintz - Health Care Viewpoints

FDA Commissioner Announces Stem Cell Enforcement Shift, Plans to Develop Comprehensive Regenerative Medicine Policies

In a major public move that has been long-awaited by proponents of evidence-based stem cell science, FDA Commissioner Scott Gottlieb issued a lengthy statement on August 28, 2017 “on the FDA’s new policy steps and enforcement...more

Mintz - Health Care Viewpoints

President Obama Signs 21st Century Cures Act; Creates Accelerated Approval Pathway for Regenerative Medicine

On Tuesday, President Obama signed the 21st Century Cures Act (the “Act”) into law. The Act is a massive piece of legislation that has implications for many different aspects of the interconnected medical research, product...more

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