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 access to key resources frozen, the FDA has announced that it will not accept or [...]

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 devices, pharma, diagnostics, and more. Pre-conference workshops will take place on October 6 and 7, [...]

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 a Marketing Application: Questions and Answers", marks an important step in how FDA plans [...]

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 an institutional shift toward modern, human-relevant evaluation methods and signals a new era in regulatory [...]