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The FDA and the Department of Defense announced a joint program Tuesday to prioritize development of medical products for deployed military personnel. Read More
FDA Commissioner Scott Gottlieb said the agency’s least burdensome approach policy approach is “a hallmark of our efforts to help innovators generate… Read More
The firm’s recordkeeping made it unclear if the issues described in customer complaints represented adverse events that should have been reported to the FDA. Read More
None of the company’s complaints from 2016 or 2017 reviewed by the FDA had been evaluated to determine whether they should be reported to the agency as adverse events. Read More
Westone Laboratories’ manufacturing facility in Oregon drew a Form 483 from the FDA for significant quality system nonconformities and equipment calibration issues. Read More
Palo Alto Health Sciences drew a Form 483 from the FDA for inadequate CAPA and complaint procedures, and for incomplete internal auditing and supplier profiles. Read More