The boom in digital tech over COVID means that pharma can move faster than ever – but the industry’s traditional processes for asset approval are still holding timelines back. David Reily examines how ...

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 ...

New excipients and improvements to existing excipients are needed to facilitate access to new drugs for patients. Novel excipients in the United States are only reviewed in the context of a new drug ...

NEW YORK (Thomson Reuters Regulatory Intelligence) - No matter what the policies are, and no matter who in your organisation writes them, they have to get approved. That approval process is vital to ...

Ethical considerations are foundational to the integrity and validity of scholarly work, guiding researchers to conduct studies that are academically sound and morally responsible. Securing ethics ...

The FDA Modernization Act of 1997 established the Fast Track designation to expedite developing and reviewing new drugs designed to fill unmet medical needs and treat serious conditions. The FDA Fast ...

Local authority social housing projects will go from a four-stage approval process to a single-stage process under reforms announced by Minister for Housing James Browne. The move is intended to speed ...