The guidance clarifies what sponsors should consider when putting together an application for the validation of a NAM ...
Health authorities in the U.S. are continuing their move away from animal testing in drug development, with the FDA signaling an openness to new approaches that haven’t been validated and the National ...
The Trump administration is redoubling its efforts to phase out animal testing in drug development and seeking to develop new ...
Add Yahoo as a preferred source to see more of our stories on Google. The FDA has introduced a new draft guidance The US Food and Drug Administration (FDA) has debuted new draft guidance that aims to ...
Federal regulators in the United States are pushing harder than ever to reduce and eventually replace animal testing in drug and chemical safety assessments. The FDA has released draft guidance ...
The wheels of medical device regulation turn slowly at times. But just like The Little Engine That Could, it usually reaches its destination eventually. One of the slowest moving regulations was FDA's ...
After the FDA’s first-ever public listening meeting on data-sharing in the cell and gene therapy space, new draft guidance aims to standardize the practice.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 ...