4:04 PM
Apr 13, 2018
 |  BC Extra  |  Politics & Policy

FDA issues final guidance on SPAs

Editor's Note: This article was updated on Apr 16, 2018 at 12:48 PM PDT

FDA published its final guidance Friday on procedures and policies for obtaining an SPA agreement, which clarifies a few details from the 2016 draft guidance on the topic (see BioCentury Extra, May 3, 2016).

The final guidance adds language stating that the agency should communicate with sponsors about issues with a protocol before sending a no SPA agreement letter.

The final guidance...

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