The FDA has proposed new policies to speed up the development and lower the cost of biosimilar agents for cancer and other serious illnesses. These policies include “major updates to simplify ...
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 ...
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FDA and EMA release collaborative AI framework for drug development
The joint guidance was created to ensure drug developers employ best practices when using AI.
The U.S. Food and Drug Administration (FDA) issued its third Patient-Focused Drug Development (PFDD) guidance titled, “Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments ...
In April 2025, the U.S. Food and Drug Administration (FDA) released a landmark guidance titled “Roadmap to Reducing Animal Testing in Preclinical Safety Studies,” outlining its commitment to advancing ...
Forbes contributors publish independent expert analyses and insights. Greg Licholai writes and teaches about innovation in healthcare. We are on a bureaucratic trajectory where American leadership in ...
The U.S. Food and Drug Administration (FDA) today announced action to make it faster and less costly to develop biosimilar medicines, which are lower-cost alternatives to expensive biologic drugs used ...
WASHINGTON, D.C. — The U.S. Food and Drug Administration has launched a pilot program aimed at dramatically speeding up the back-and-forth communications between drug developers and federal regulators ...
The US Food and Drug Administration will take steps to streamline the development of generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to accelerate ...
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