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

The U.S. Food and Drug Administration issued a draft guidance on Wednesday to help drug developers validate alternative methods that can be used in place of animal studies during early stages of drug ...

The Trump administration is redoubling its efforts to phase out animal testing in drug development and seeking to develop new ...

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 ...

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 The FDA has introduced a new draft guidance The US Food and Drug Administration (FDA) has debuted new draft guidance that aims to ...

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 ...

The U.S. Food and Drug Administration (FDA) recently finalized its guidance document, Computer Software Assurance for Production and Quality System Software, for software used in device production and ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

After the FDA’s first-ever public listening meeting on data-sharing in the cell and gene therapy space, new draft guidance aims to standardize the practice.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