Remove Drugs Remove FDA Compliance Remove Life Science
article thumbnail

FDA Refines Accelerated Approval Pathway with New Draft Guidance

XTalks

The US Food and Drug Administration (FDA) has released a new draft guidance titled Expedited Program for Serious Conditions Accelerated Approval of Drugs and Biologics Guidance for Industry refining the accelerated approval pathway for drugs and biologics targeting serious or life-threatening conditions.

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How FDA’s AI Draft Guidance Aims to Bring Transparency to Drug Development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The US Food and Drug Administrations (FDAs) new draft guidance , Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products , provides a roadmap for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What the FDA’s Draft Guidance for AI-Enabled Medical Devices Means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This announcement aligns with the FDA’s release of the draft guidance for AI in drug and biological product development , signaling a unified effort across healthcare. Such omissions hinder transparency, restrict performance evaluations and risk exacerbating health disparities among underrepresented populations.