FDA Law Blog

JANUARY 1, 2024

Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. If FDA wanted to create that impression, it likely succeeded. They have great impact on most companies that receive them.

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Cloudbyz

AUGUST 19, 2024

Medical device safety is a multifaceted discipline encompassing the design, manufacturing, testing, and monitoring of devices throughout their lifecycle. Manufacturers must adhere to a wide array of standards and guidelines that dictate how devices are developed, tested, and brought to market.

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XTalks

JANUARY 8, 2025

The US Food and Drug Administrations (FDAs) new draft guidance , Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products , provides a roadmap for integrating artificial intelligence (AI) into regulatory decisions for drug and biological product development.

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XTalks

JANUARY 9, 2025

The FDAs new draft guidance for developers of AI-enabled medical devices marks a critical milestone in addressing the complexities of transparency, bias and safety throughout the lifecycle of these advanced technologies.

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FDA Law Blog

JUNE 9, 2021

Koblitz — While typically, FDA is responsible for setting forth its own agenda and enforcing compliance with its own regulations, the Trump Administration’s HHS, on its way out the door in late 2020 , took the unusual steps of withdrawing an important FDA Compliance Policy Guide, “Marketed Unapproved Drugs – Compliance Policy Guide Sec.

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