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Improving inspection activities and concentrating on postmarket surveillance to enhance patient safety are two areas where Brazil’s Agência Nacional de Vigilância Sanitária made strides in 2014, according to a new report. Read More
To comply with FDA’s combination product good manufacturing practices, both devicemakers and drugmakers should first look at their systems and conduct a gap analysis using both the quality system regulation and drug cGMPs. Read More
Olympus is facing tough questions from the FDA following inspections conducted in April and May of four facilities that manufacture duodenoscopes. The company — along with Pentax and Fujifilm — is facing scrutiny after improper cleaning of its complex endoscopes was linked to patients becoming sick or dying. Read More