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The FDA warned investigational medical device sponsor UVLrx Therapeutics for failing to obtain required authorization from its Institutional Review Board. Read More
A major manufacturer of generic drugs in India failed to follow up as required on laboratory tests that showed its products at two facilities did not meet specifications, in some cases improperly dismissing the red-flag results, the FDA said in a warning letter. Read More
The FDA cited a drug outsourcing facility in Bethlehem, Penn., for numerous compliance problems including inadequate computer security and lax labeling practices. Read More
The FDA cited an Illinois provider of home infusion therapy for failing to meet sterile production standards, according to a warning letter from the agency. Read More
UK regulators moved to block imports to the European Union from a generic drug manufacturer in India after reporting deficiencies in quality control, processing, laboratory testing and safeguards against contamination. Read More
The FDA will begin to recognize manufacturing facility inspections conducted by eight European drug regulatory authorities as capable of meeting the agency’s requirements, as part of 1998 agreement between the U.S. and the European Union renegotiated earlier this year. Read More
Problems with handling complaints, maintaining sterile production conditions and following up on testing crop up in reports of on-site inspections. Read More
The FDA pharmaceutical inspector of tomorrow will be more specialized by training and more likely to work abroad, a high-ranking agency official told an FDAnews regulatory conference. Read More