Pair of Anti-Malaria Drugs Win Approval

The sponsors will conduct post-marketing studies to make sure their drugs are safe and effective for children, elders and the obese. 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 Innovative Devices to Treat Opioid Use Disorder

The challenge is part of the FDA's ongoing work to reduce the scope of the opioid crisis. 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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