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 ...

The U.S. Food and Drug Administration (FDA) has issued draft guidance on its “Platform Technology Designation Program,” which aims to streamline drug development, manufacturing, and marketing ...

In December 2016, the bipartisan 21st Century Cures Act (P.L. 114-255) was enacted, marking a pivotal milestone in advancing a patient-focused drug development (PFDD) paradigm. This law directed the ...

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 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) has issued final guidance describing its process for recognizing voluntary consensus standards (VCS) to spur the development of regenerative medicine ...

“Cybersecurity is a really important part of your system, and you need to make sure that it's part of your thought process from day one, when you're designing and architecting your device, all the way ...

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

The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.

Please provide your email address to receive an email when new articles are posted on . An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy ...