Medical Device and Diagnostic Industry (MD+DI)

FDA’s AI Device Regulations: Key Updates & Compliance Strategies for Medtech Success

In the past 18 months, the FDA has outlined clear guidelines for designing, documenting, updating, and monitoring AI-powered ...

FDA shares guide on genome editing best practices

This guidance emphasises the potential of NGS methods in mitigating safety risks associated with therapies incorporating ...
BioSpace

FDA bolsters bespoke therapy framework with new draft safety guidelines

The draft guidance supports the agency’s new pathway designed to speed up the development of custom gene therapies.
Becker's Hospital Review

FDA issues new guidance on compounded GLP-1 production

FDA issues guidance compounded GLP-1 production limits, restricting pharmacies to compound only during active shortages to ensure drug safety and ...
Regulatory Affairs Professionals Society

FDA drafts guidance on using next-generation sequencing to assess gene therapy safety

The US Food and Drug Administration (FDA) has released draft guidance on how sponsors can utilize next-generation sequencing ...
Becker's Hospital Review

5 FDA moves shaping drug development, oversight

FDA moves shaping drug development and oversight include new gene therapy guidance, clinical trial transparency efforts, and recent drug approvals.
ABC30 Action News

FDA issues new sodium guidelines, renewing pressure for food makers to use less salt

WASHINGTON -- The US Food and Drug Administration said Wednesday it will be lowering its targets for sodium content in processed, packaged, and prepared foods, but not to levels recommended for ...
12 NEWS

AI drug creation guidelines released by the FDA

WASHINGTON, D.C., USA — The U.S. Food and Drug Administration on Wednesday released 10 new guidelines for drug manufacturers to follow when using artificial intelligence to develop new treatments. The ...