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 ...
BioSpace2d
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 ...
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 ...
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 ...
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 ...
Medical Xpress29d
New path toward faster drug approvals for multiple myeloma treatment
an expedited FDA process tailored to new treatments for serious or life-threatening diseases. Landgren said the result will be streamlined drug development, clinical testing and regulatory review ...
FDA sets new lead level guidelines for baby foods
FDA introduces guidelines for lead levels in processed baby foods, aiming to enhance infant safety and reduce exposure to ...
GlobalData on MSN7d
FDA grants pre-market approval to HLB Life Science’s disposable syringe
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