RAPS

FDA Outlines Product Development Process to Combat Wuhan Coronavirus

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 ...
MD&M East

Ten Steps to Speeding Product Development While Meeting FDA Mandates

The path to successful product development for medical device companies is rife with roadblocks. The recession has only added to the pressures of mounting regulatory requirements, particularly those ...
JD Supra

You Can’t Call It Cheatin’: FDA Draft Guidance Provides a Framework for Leveraging Prior Knowledge in Genome Editing Product Development

You can’t call it cheatin’, she reminds me of you,” the Gin Blossoms sang on their 1996 album Congratulations I’m Sorry. For sponsors ...
Healthline

The FDA Development and Approval Process for Medications and Medical Devices

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 ...