Pharm Exec3d
Challenges to Navigating the Pharmaceutical Regulatory Landscape
In the United States, the biomedical industry encounters numerous regulatory challenges in conducting nonclinical and ...
JD Supra11d
FDA Issues Detailed Guidance for Biopharma Industry on What Information to Provide to FDA About Use of AI Models
On January 7, 2025, the Food and Drug Administration (FDA) made available a draft guidance for industry (GFI) titled “Considerations for the Use ...
GlobalData on MSN1d
FDA protocol deviation guidance could go further
The US Food and Drug Administration has released draft guidance on protocol deviations, but experts say it could go further.