FDA Warns Three Kratom Distributors Over Unproven Opioid Treatment Claims

FDA Commissioner Scott Gottlieb said the agency “cannot allow unscrupulous vendors to take advantage of consumers by selling products with… Read More

International Devices and Diagnostics Monitor

Stay ahead of the competition with this resource that brings you a global picture of the medical device regulations that affect your business. Read More

FDA Seeks to Improve Medical Devices for Women

Improving analysis and data collection will require the development of common data elements for sex and gender to be included in some prominent medical device registries, said FDA Commissioner Scott Gottlieb.  Read More

483sOnline.com Your Personal Pre-inspection Toolkit

Rest easy knowing you can identify exactly what FDA investigators are focusing on – before they show up! Read More
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