FDA, AI

FDA’s new guidance on AI in drug development centers the risk introduced by the technology
After nearly a decade of machine learning innovations, the FDA has issued its first draft guidance on the use of AI in drug development.
FDA’s New AI Guidance Highlights Risks of Technology, Urges Early Sponsor Engagement
The FDA’s guidance on AI in drug development points to potentially life-threatening consequences of the technology, highlighting the importance of providing the regulator with detailed information regarding models’ development and maintenance.
Amid booming market, US FDA advises on obesity drug development
With obesity drugs taking the U.S. and global markets by storm and more than 100 clinical programs currently in progress for the drugs, the U.S. FDA released a draft guidance Jan. 7 to help sponsors develop drugs and biologics for weight reduction and long-term maintenance of body weight.
FDA issues first draft guidance on use of AI in drug, medical device development
Recognizing the increased use of artificial intelligence in the development of new therapies, the U.S. FDA on Monday released separate draft guidance on the use of the technology in the development of new drugs and medical devices.
FDA drafts guidance for AI developers
The agency announced Monday it was issuing draft guidance that will assist developers as they work through life cycle of their AI-enabled medical devices, said Troy Tazbaz, director of the FDA’s digital health center of excellence.
The Prescription For Change: Five Ways Tech Can Improve Drug Pricing While Supporting Innovation
Drug pricing is influenced by numerous factors, but technology has the potential to strike the critical balance between ...
Will AI revolutionize drug development? Researchers explain why it depends on how it’s used
Researchers have applied AI to every step of the drug development process. But this might not be enough to design safe and ...
FDA expands drug access with self screening rule
Rule could make more medications available over the counter through a process called Additional Condition of Non-prescription Use (ACNU).
How a single nitrogen atom could transform the future of drug discovery
Researchers at the University of Oklahoma have developed a breakthrough method of adding a single nitrogen atom to molecules, ...
JD Supra1d
Balancing Safety and Accessibility: FDA Broadens Approval Pathway for Nonprescription Drugs by Finalizing the ‘ACNU’ Rule
The US Food and Drug Administration (FDA) has announced a final rule expanding the approval pathway for nonprescription drug ...
Healio1d
Cour Pharmaceuticals snags orphan drug designation for CNP-104 for the treatment of PBC
The FDA has granted Cour Pharmaceuticals orphan drug designation for CNP-104, a biodegradable nanoparticle in development for ...