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 ...
BioSpace

FDA Blueprint Aims To Cut Regulatory Risk for Alternatives to Animal Testing

Draft guidance, issued by the FDA last week, could remove ambiguity and uncertainty that may have so far limited uptake of ...
FierceBiotech

FDA plans to end animal testing requirements for monoclonal antibody drugs

The FDA is moving away from requiring animal models for investigational new drug (IND) applications for new monoclonal antibodies and some other drug candidates. Animal testing will be "reduced, ...
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 ...
KJCT8

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 ...
Fierce Pharma

FDA unveils 4th revision of draft guidance for looser biosimilar testing requirements

The FDA is doubling down on its goal to increase biosimilar drug availability in the U.S. | The FDA's newest draft guidance reinforces its previous commitment to streamlining biosimilar drug ...