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The US Food and Drug Administration (FDA) has released draft guidance on how sponsors can utilize next-generation sequencing ...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, ...
Physicians Committee for Responsible MedicineOpinion

FDA Endotoxin Testing Update Falls Short for Nonanimal Methods

A recent guidance update from the U.S. Food and Drug Administration (FDA) on pyrogen and endotoxins testing represents a ...
C&EN

2-in-1 mass spec method speeds up drug discovery

An illustration of an antibody disrupting the binding between a virus particle and a receptor on the edge of a membrane. A drug (orange) blocks the SARS-CoV-2 virus (gold sphere with white protruding ...
Reuters

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

March 18 (Reuters) - The U.S. Food and Drug Administration on Wednesday issued a draft guidance to help companies reduce animal studies of experimental drugs and adopt newer methods, such as computer ...