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The European Commission formally adopted updated regulations on good manufacturing practices for pharmaceuticals generally and for investigational drugs and clinical trials more specifically. 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The FDA’s draft guidance on post-approval manufacturing changes for biological products needs work to clarify how it fits with previous agency documents, according to written comments on the draft. 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 European Medicines Agency added new safety information for 15 excipients, including five new ingredients, in its listings of required product labeling. 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
Ensuring data integrity is a crucial task for drug manufacturers wishing to stay out of trouble with the FDA, a top enforcement official at the agency told an industry conference. Read More