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The US Food and Drug Administration (FDA) has released draft guidance on how sponsors can utilize next-generation sequencing ...
Yahoo

US FDA pushes for new methods to replace animal testing in early drug studies

Add Yahoo as a preferred source to see more of our stories on Google. FILE PHOTO: The corporate logo of the U.S. Food and Drug Administration (FDA) is shown in Silver Spring, Maryland, November 4, ...
Regulatory Affairs Professionals Society

EMA proposes new method to reduce animal drug testing

Following the trend of other regulators, the European Medicines Agency (EMA) is taking steps to reduce the need for animal testing. The agency has issued a draft qualification opinion for a new ...