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Regulatory Requirements › Life Sciences › Drug Safety

Blake, Cassels & Graydon LLP

Health Canada Proposes Regulations to Mitigate Drug and Medical Device Shortages

Blake, Cassels & Graydon LLP on

Health Canada recently published draft regulations to address therapeutic product shortages in Canada. The Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Shortages and Discontinuation of Sale of...more

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A Model’s Credibility Is in the Details: FDA Draft Guidance on the Use of AI Models in Drug and Biological Product Development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FDA Issues Draft Guidance Describing When a Confirmatory Trial of a Drug Seeking Accelerated Approval Is “Underway”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

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