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 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 ...

Allarity Therapeutics Announces CLIA Certification, Clearing the Path for Advancing DRP® Testing for FDA Registration

Allarity Therapeutics is now poised to run its DRP® testing in-house in a CLIA-certified laboratory environmentThe FDA requires that ...
KFVS12

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Our FDA/Food, Drug & Device Team reviews how new draft guidance from the Food and Drug Administration (FDA) can help manufacturers better understand requirements for drug product manufacturing.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