Proposed US rules on drug detention may pose new risk during inspections
This article was originally published in SRA
The US Food and Drug Administration has issued a proposed regulation that would provide FDA officers conducting inspections with the administrative authority to detain drugs that they believe are either adulterated or misbranded1.
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This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.
New medicines under evaluation at the European Medicines Agency.
The European Medicine Agency has recommended extending the therapeutic indication of a raft of drugs that are already authorized in the EU.