Bert Lao

Jan 22, 2025 | jdsupra.com | Melissa Bianchi |Ashley Grey |Bert Lao

The U.S. Food and Drug Administration (FDA) recently published its long-awaited draft guidance on considerations for the use of artificial intelligence (AI) to support regulatory decision-making for drug and biologics, which provides a comprehensive, risk-based framework to help sponsors evaluate and manage AI models.

Jan 2, 2024 | jdsupra.com | David Horowitz |Bert Lao

January 2, 2024 To embed, copy and paste the code into your website or blog: In December 2023, the U.S. Food and Drug Administration (FDA) issued nine Warning Letters for the manufacture and distribution of unapproved over-the-counter (OTC) antimicrobial animal drugs for use in aquarium fish and birds.