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More drugmakers have weighed in on the FDA’s draft guidance on biosimilar interchangeability, urging the agency to make clear the designation does not mean a product is superior in terms of safety or efficacy. Read More
The FDA issued a warning letter to Merrill Benson, a faculty member at Indiana University School of Medicine, over insufficient blood and panel testing of subjects observed at a clinical trial site following a Form 483. Read More
The Association of Clinical Research Professionals published its final Core Competency Framework for Clinical Study Monitoring, outlining the main skills needed throughout the clinical research associate workforce. Read More
The Association of Clinical Research Professionals and CRO Analytics announced a joint initiative to provide clinical research organizations with performance and quality measurements, and analysis of real-world data. Read More
The Association of Clinical Research Professionals announced a new certification this past month, the Certified Professional program, open to all working in clinical studies. Read More
In a Tuesday meeting, the FDA’s Science Board reviewed and largely supported the agency’s proposed plan for implementing the 21st Century Cures Act over the next nine years. Read More
The EMA says it will continue to invite patients to in-person discussions between reviewers and product sponsors — following a successful two-year pilot project involving five medicines. Read More
For the development of generic versions of naloxone, an emergency nasal spray treatment for opioid overdoses, the FDA said it will allow sponsors to demonstrate bioequivalence using solely in vitro performance tests — as long as the generic is qualitatively the same as the reference product. Read More