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The FDA is faulting a clinical investigator for neglecting to follow the established procedures for a trial testing a new investigational drug. Read More
British authorities are ordering an Indian manufacturer to recall batches of progesterone injections after an inspection turned up one critical GMP violation and three major ones at one of its facilities. Read More
The FDA has handed Boehringer Ingelheim a 10-observation Form 483 for delays with a field alert report, as well as sanitation and sterilization procedures at a site in Germany. Read More
Spanish regulators are recommending that EU officials suspend a manufacturing certificate from a Chinese API maker over repeated issues at its plant. Read More
A compounding operation in North Carolina landed an FDA warning letter for compounding drugs without prescriptions and for sterility concerns. Read More