Remove FDA Compliance Remove Production Remove Regulation
article thumbnail

How FDA’s AI Draft Guidance Aims to Bring Transparency to Drug Development

XTalks

The US Food and Drug Administrations (FDAs) new draft guidance , Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products , provides a roadmap for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

article thumbnail

What the FDA’s Draft Guidance for AI-Enabled Medical Devices Means

XTalks

This announcement aligns with the FDA’s release of the draft guidance for AI in drug and biological product development , signaling a unified effort across healthcare.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

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

FDA Law Blog

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.

article thumbnail

Comprehensive Guide to Medical Device Safety, Systems, and Regulatory Compliance: FAQ

Cloudbyz

Introduction to Medical Device Safety, Systems, and Regulations The medical device industry is a rapidly evolving field that plays a critical role in modern healthcare. This is where the importance of stringent safety processes, robust systems, and comprehensive regulations comes into play. What is the Medical Device Safety process?

article thumbnail

FDA Flips It and Reverses It: FDA Withdraws HHS Withdrawal of UDI Guidance

FDA Law Blog

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.