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Sanofi alleges Novo Nordisk engaged in a national advertising campaign that falsely claimed access to Sanofi’s diabetes therapies Lantus and Toujeo would be restricted next year. Read More
Aplicare landed an FDA warning letter after an inspection uncovered four significant GMP violations involving sterility controls and marketing claims for unapproved uses. Read More
The FDA updated its guidance for botanical drug development to include recommendations for navigating combination drug regulations, with possible criteria for receiving a waiver. Read More
The FDA served Wells Pharmacy Network with a six-observation Form 483 for failing to maintain adequate sterility controls and an acceptable state of repair at its Tennessee facility. Read More
FDA’s San Juan district office has found numerous problems at a Baxter sterile drug manufacturing facility in Jayuya, Puerto Rico following a series of inspections in late August through early October. Read More
The European Medicines Agency began reviewing data related to studies performed by Micro Therapeutic Research Labs at two sites in India, following a clinical practice inspection in February. Read More