RAPS

FDA Releases Annual Report on Biological Product Deviations

The US Food and Drug Administration's (FDA) Center for Biologics Research and Evaluation (CBER) on Wednesday released its annual summary of manufacturing deviations reported by biologics, blood and ...
RAPS

Stakeholders seek clarity, use of international standards in FDA protocol deviations guidance

Industry groups are asking the US Food and Drug Administration (FDA) for more clarity about a proposed uniform system for classifying protocol deviations in clinical studies. They say clarification is ...