Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
FDA announces new, consumer-friendly MedWatch form. Agency issues final guidance on injector devices used with drugs or biologics. More regulatory news.
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First MERS-CoV In U.S. Diagnosed With FDA Emergency-Authorized Test Kit
The first documented Middle East respiratory syndrome coronavirus (MERS-CoV) case has appeared in the U.S., the Centers for Disease Control and Prevention confirmed May 2, and the individual was diagnosed with an MERS testing kit developed by CDC and approved for emergency use by FDA last June.
FDA Puts Strengthened Emergency Authority To Use For Diagnostics
The agency’s diagnostic office is putting to the test new authority to grant emergency use authorization for a product before an emergency is officially declared, with an upcoming coronavirus test and a recently authorized flu test.
Regulatory News In Brief
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