"FDA and EMA release collaborative AI framework for drug development" was originally created and published by Pharmaceutical ...

The U.S. Food and Drug Administration and the European Medicines Agency jointly issued principles for safe and responsible ...

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 ...

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 ...

Biotech companies developing drugs for hard-to-treat diseases and other ailments are being forced to push back clinical trials and drug testing in the wake of mass layoffs at the Food and Drug ...

According to the Food and Drug Administration (FDA), the traditional paradigm of medical device regulation was not designed for adaptive artificial intelligence and machine learning technologies. As a ...

CAMBRIDGE, Mass., Jan. 23, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application ...

Six weeks after a reduction in force (RIF) at the US Food and Drug Administration removed thousands of workers, signs are emerging about how the agency’s approach to drug approval may change. The 20% ...

The FDA will begin replacing animal testing in the development of monoclonal antibody therapies and other drugs with human-based methods. The agency said the new approach will aim to improve drug ...

The "Human Factors and Usability Engineering in the Development of Drug Delivery Products Training Course (Feb 11th - Feb 12th, 2026)" training has been added to ResearchAndMarkets.com's offering.