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The FDA is on track to complete standardized inspection agreements with every nation in the European Union next summer, one of the agency’s top international officials said Friday. Read More
The FDA has cut the amount of time it takes to issue post-inspection classification letters nearly in half over the past three years, one of the agency’s top inspection officials said Friday. Read More
The FDA hit drug compounder Fusion IV with a warning letter after an agency inspection found numerous problems at its outsourcing facility including the failure to meet conditions for section 503B exemptions from the agency’s drug approval requirements. Read More
The EMA noted a steep decrease in GMP inspections in its annual report for 2017, as well as a hike in inspections for good clinical practices and nearly double the amount of pharmacovigilance inspections than the previous year. Read More
Investigators found several complaints for which there was no documentation of an evaluation to determine if there were similar complaints for different strengths of the synthetic hormone. Read More
The FDA hit drug compounder Fusion IV with a warning letter after an agency inspection found numerous problems at its outsourcing facility including the failure to meet conditions for section 503B exemptions from the agency’s drug approval requirements. Read More
Recent FDA warnings and untitled letters show the agency’s enforcement efforts for advertising and promotion are focused on product risk information and pre-approval promotions for investigational drug products, according to two Ropes and Gray attorneys. Read More