The US Food and Drug Administration (FDA) on Monday issued a statement explaining how the agency can facilitate the development of investigational products to diagnose, treat and prevent emerging ...

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 ...

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 ...

In a Q&A, an FDA spokesperson discusses efforts to reduce misinformation about biosimilars through education, the agency’s collaboration with global regulators to streamline development, and its work ...

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, ...

The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have proposed a parallel ...

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 ...

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 ...

Faster Medicare Coverage. The Centers for Medicare & Medicaid Services (CMS) and the U.S. Food and Drug Administration ...

TEMECULA, CA, UNITED STATES, February 20, 2026 /EINPresswire.com/ — Dr. Goodenowe Dietary Therapeutics LLC, a U.S.-based company formed to advance selected dietary ...