FDA outlines plan to phase out animal testing in new draft guidance

The guidance clarifies what sponsors should consider when putting together an application for the validation of a NAM ...

FDA issues guidance on alternatives to animal testing

The U.S. Food and Drug Administration issued a draft guidance on Wednesday to help drug developers validate alternative methods that can be used in place of animal studies during early stages of drug ...
Fierce Biotech

FDA, NIH pledge more flexibility and $150M investment for animal testing alternatives

Health authorities in the U.S. are continuing their move away from animal testing in drug development, with the FDA signaling ...

Trump HHS ramps up biotech to phase out animal testing

The Trump administration is redoubling its efforts to phase out animal testing in drug development and seeking to develop new biotechnology methods instead to spur innovation in the pharmaceutical ...
European Medical Journal

FDA backs shift to alternatives to animal testing

The FDA has released draft guidance aimed at helping drug developers shift away from traditional animal testing as the standard.
JD Supra

FDA Issues Draft Guidance for Responses to Form 483 Drug CGMP Inspections

On March 9, 2026, the Food and Drug Administration (FDA) published a draft guidance, “Responding to FDA Form 483 Observations at the Conclusion of ...
BioSpace

Why Industry Is Questioning FDA’s Data-Sharing Push in Cell and Gene Therapy

After the FDA’s first-ever public listening meeting on data-sharing in the cell and gene therapy space, new draft guidance aims to standardize the practice. But recent decisions call into question ...