Clinical Research, FDA Compliance and Production

FDA End-of-Year Release of Warning Letters Impresses (or Depresses)

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.

Manufacturing

Manufacturing Production Drugs Contract Manufacturing

How FDA’s AI Draft Guidance Aims to Bring Transparency to Drug Development

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The US Food and Drug Administrations (FDAs) new draft guidance , Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products , provides a roadmap for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

Development

Development Drugs Compliance Clinical Trials

Clinical Research Informer

FDA End-of-Year Release of Warning Letters Impresses (or Depresses)

How FDA’s AI Draft Guidance Aims to Bring Transparency to Drug Development

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