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 ...
KTRE

FDA to phase out animal testing requirements

(CNN) - The Food and Drug Administration said it will phase out a requirement that certain drugs and monoclonal antibodies be tested on animals. In a statement, the FDA said it’s taking this step ...
FierceBiotech

FDA plans to end animal testing requirements for monoclonal antibody drugs

The National Association for Biomedical Research said that "there is currently no full replacement for animal models in biomedical research and drug development." (iStock / Getty Images Plus) The FDA ...
The Hill

FDA to phase out some animal testing requirements, possibly replace them with AI models

The Food and Drug Administration (FDA) announced Thursday it plans to phase out animal testing requirements for biological products and drugs, instead moving toward alternative testing models such ...
JD Supra

Manufacturers Take Note: FDA Clarifies In-Process Sampling Under Section 211.110

Our FDA/Food, Drug & Device Team reviews how new draft guidance from the Food and Drug Administration (FDA) can help manufacturers better understand requirements for drug product manufacturing. The ...
Regulatory Affairs Professionals Society

FDA to exempt five more unclassified devices from premarket notification

The US Food and Drug Administration (FDA) announced its intent on Thursday to exempt certain unclassified medical devices from premarket notification requirements.