Clinical Research, FDA Compliance and Manufacturing

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

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.

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How FDA’s AI Draft Guidance Aims to Bring Transparency to Drug Development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The US Food and Drug Administrations (FDAs) new draft guidance , Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products , provides a roadmap for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How FDA’s AI Draft Guidance Aims to Bring Transparency to Drug Development

Webinars

Stay Connected