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Less that a third of regulatory actions spurred by safety signals in the FDA Adverse Event Reporting System (FAERS) weresupported by published studies, with most actions relying instead on case reports and none corroborated by FDA’s Sentinel Initiative, researchers at Yale University reported in the journal BMJ. Read More
Companies submitting or holding drug applications who plan to implement a chemistry, manufacturing, and controls (CMC) postapproval change may gain faster agency reviews using a comparability protocol (CP), according to a final guidance the FDA released on Thursday. Read More
After years of legal wrangling, the FDA is still grappling with the issue of how exactly to define “exclusivity” in its orphan drug program, according to one senior agency official who says legislative action may be needed to end the debate. Read More
COVID-19 exposed supply chain problems that should have pharmaceutical manufacturers rethinking their standard procedures — from sourcing manufacturing materials to getting completed product safely into customer hands, — says one regulatory compliance expert. Read More
The FDA has settled litigation by the Outsourcing Facilities Association (OFA) accusing the agency of unlawfully delaying the inclusion of new bulk substances on its approved list of ingredients for compounding. Read More