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Three clinical investigators were cited for deviating from their investigational plans recently by the FDA for a litany of different reasons. Read More
The FDA handed a 10-observation Form 483 to a Texas manufacturer for sterility shortcomings, inadequate testing of products and deficient recordkeeping. Read More
In the latest of a string of manufacturing snafus plaguing Indian drugmakers, the French National Agency for Medicines and Health Products Safety is calling for the withdrawal of Anuh Pharma’s GMP certificate. Read More