Regulatory Affairs Professionals Society

FDA draft guidance sets impurity controls for most antibiotics

The US Food and Drug Administration (FDA) has released a draft guidance document aimed at setting impurity limits for ...

Rocket Science Health Secures Foundational Patent Establishing Exclusive Nasal "Right-of-Way" for Targeted Drug Administration

CNW/ - Corp., a Canadian healthcare technology company, today announced the issuance of a new method patent from the United ...
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

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The US Food and Drug Administration (FDA) has released draft guidance on how sponsors can utilize next-generation sequencing ...
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 ...
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March 18 (Reuters) - The U.S. Food and Drug Administration on Wednesday issued a draft guidance to help companies reduce animal studies of experimental drugs and adopt newer methods, such as computer ...