FDA Law Blog

JANUARY 1, 2024

Four of the letters addressed failure to comply with drug Current Good Manufacturing Practice regulations, four more stated that the recipients were distributing unapproved drug products, two alleged violations of the Quality System Regulation by medical device manufacturers, and one was addressed to a clinical investigator.

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Cloudbyz

AUGUST 19, 2024

This process includes the following key stages: Risk Assessment: Identifying potential risks associated with the device’s design, production, and use. Answer: The EU Medical Device Regulation (MDR) is a regulation that governs the production and distribution of medical devices in the European Union.

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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The US Food and Drug Administrations (FDAs) new draft guidance , Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products , provides a roadmap for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

This announcement aligns with the FDA’s release of the draft guidance for AI in drug and biological product development , signaling a unified effort across healthcare.

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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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