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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
The FDA intends to publish a proposed rule that would replace current requirements for reports submitted on IND applications, according to an HHS inventory of agency rulemaking for 2017. Read More