RAPS

FDA trims reserve testing quantity requirements

Reflecting changes in testing technology, a new and immediately effective guidance from the US Food and Drug Administration (FDA) updates the agency’s approach to retention of reserve samples for ...
RAPS

Draft guidance outlines FDA’s testing requirements for tissue containment systems

A new draft guidance from the US Food and Drug Administration (FDA) lists potential non-clinical testing requirements for tissue containment systems used in power morcellation surgeries. The objective ...
Healio

FDA takes steps to reduce animal testing requirements for monoclonal antibodies

Please provide your email address to receive an email when new articles are posted on . The FDA plans to reduce and potentially replace animal testing for developing monoclonal antibody therapies and ...
FierceBiotech

FDA issues draft guidance to reduce primate testing for certain antibodies

The FDA has released a plan to stop or reduce the use of primates for testing the safety of certain monoclonal antibodies (mAbs), the latest expansion of the regulator’s efforts to eliminate animal ...
National Academies of Sciences%2c Engineering%2c and Medicine

Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety ...

To gain a foundation on which to build its discussions, the committee commissioned two former Center for Devices and Radiological Health (CDRH) staff to draft a background paper on the 510(k) or ...