The U.S. Food and Drug Administration has launched a project to overhaul its application development process to provide management with a view into the agency’s IT projects. The 12-month project, ...
On September 3, 2025, the US Food and Drug Administration (FDA) announced a new process to support the development of drugs intended to treat rare genetic diseases. The Rare Disease Evidence ...
Global harmonization of CMC guidelines is a key focus for top pharmaceutical consultants. Variations in regulatory requirements across regions often create inefficiencies in drug development—for ...
When pharmaceutical companies develop a novel drug for the market, several steps are required to assess and regulate its safety, effectiveness, manufacturability, and reliability. These processes, and ...
Morning Overview on MSN
FDA urges alternatives to animal testing in early-stage drug development
The U.S. Food and Drug Administration is actively steering drug developers away from traditional animal studies and toward human-biology-based testing methods for monoclonal antibody programs. The ...
On August 6, the Food and Drug Administration (FDA) and Clinical Trials Transformation Initiative (CTTI) held a joint workshop to explore “Artificial Intelligence in Drug & Biological Product ...
When a development team is working on a piece of software, and they have a fundamental question about how the piece of software will be treated at FDA, the regulatory affairs professional cannot ...
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 ...
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