National Academies of Sciences%2c Engineering%2c and Medicine

Federal Agency Roles in Cancer Drug Development from Preclinical Research to New Drug Approval: The National Cancer Institute and the Food and Drug Administration

Suggested Citation: "3 The Food and Drug Administration." Institute of Medicine and National Research Council. 2005. Federal Agency Roles in Cancer Drug Development from Preclinical Research to New ...
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 ...
GEN

The Impact of FDA’s Animal Use Shift on the Future of Preclinical Testing

AI-based approaches are increasingly capturing complex human disease biology directly, without the use of potentially confounding animal models. [ignatiev / Getty Images] The recent decision by the ...
Seeking Alpha

Ruvidar More Effective in the Treatment of Herpes than FDA-Approved Treatments

Ruvidar(TM) demonstrates higher efficacy in the treatment of Herpes Simplex Virus, Type 1 versus FDA-approved, standard of care treatments Acyclovir and Abreva in a preclinical animal model. Toronto, ...
Healthline

The FDA Development and Approval Process for Medications and Medical Devices

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

Human intestinal cell model enables precise detection of drug-induced barrier damage

Researchers have developed a human intestinal cell model that closely mimics the structure and function of the human gut, enabling more precise prediction of drug-induced gastrointestinal toxicity ...
The Scientist

Understanding the Drug Development Process

Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...