The start of October 2025 brought an unusual complication for the life sciences industry - a partial U.S. government shutdown that has significantly limited FDA operations. With much of the agency’s staff on furlough and [...]

Starting today, October 6th, and ending on October 7th, regulatory professionals from around the world will gather in Pittsburgh, Pennsylvania for RAPS Convergence 2025, the go-to conference for insights, networking, and future-focused discussions in medical [...]

The FDA issued a new guidance on the use of “alternative tools” for assessing manufacturing facilities as part of the drug and biologics approval process. This guidance, titled "Alternative Tools for Assessing Manufacturing Facilities Named [...]

In April 2025, the U.S. Food and Drug Administration (FDA) unveiled their roadmap designed to reduce, refine, and potentially replace animal testing, beginning with monoclonal antibody therapies and expanding to other drug modalities. This marks [...]

In June 2025, the U.S. Food and Drug Administration (FDA) issued a long-anticipated draft guidance that clarifies the process for transferring ownership of 510(k) clearances. The document: “Transfer of a Premarket Notification (510(k)) Clearance” addresses [...]

On July 17, 2025, President Donald Trump issued an executive order granting 39 medical device sterilization facilities a two-year extension to comply with new ethylene oxide (EtO) emissions limits. This move follows months of industry [...]