FDA Proposes Voluntary Consensus Standards to Help Speed Drug Reviews

The standards would be listed in a publicly searchable database. 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FDA Issues Draft Guidance on Requests for Nonbinding Feedback After Inspections

If the company is also submitting a response to a 483, the agency recommends including… 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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