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Our FDA/Food, Drug & Device Team reviews how new draft guidance from the Food and Drug Administration (FDA) can help manufacturers better understand requirements for drug product manufacturing.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

FDA efforts to reduce animal testing signal shift toward AI, organ-on-chip study methods

In April 2025, the FDA announced plans to shift biomedical research for monoclonal antibodies and other medications away from animal testing toward new approaches. One year later, much speculation ...
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FDA unveils 4th revision of draft guidance for looser biosimilar testing requirements

The FDA is doubling down on its goal to increase biosimilar drug availability in the U.S. | The FDA's newest draft guidance reinforces its previous commitment to streamlining biosimilar drug ...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

March 13 Policy Watch: FDA streamlines its process for approving biosimilar drugs

In another development, 25 states have petitioned to join a lawsuit and defend the EPA’s decision to rescind the climate endangerment finding ...
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 ...
Becker's Hospital Review

FDA looks to further ease biosimilar approvals

FDA looks further ease biosimilar approvals by allowing foreign clinical data and reducing pharmacokinetic study requirements to cut costs.

FDA to ease testing rules to speed biosimilar approvals – Bloomberg News reports

The U.S. ‌Food ‌and Drug Administration ​plans to ease testing requirements ‌for companies ⁠developing biosimilar drugs, ⁠aiming to make ​it ​simpler ​and faster ‌to bring lower‑cost alternatives to ...
Benzinga.com

Health Care Technology Stocks Surge After FDA Announces Plans To Phase Out Animal Testing Requirements

Several stocks in the health care technology space are moving higher after the market close on Thursday after the U.S. Food and Drug Administration (FDA) announced plans to phase out animal testing ...