Thursday, 23 January 2014

FDA Guidance on Clinical Site Data


FDA has issued draft guidance: Specifications for Preparing and Submitting Summary Level Clinical Site Data for CDER’s Inspection Planning, which provides current FDA specifications for preparing and submitting a summary-level clinical-site dataset in electronic form for NDAs, BLAs, and NDA or BLA supplemental applications submitted to FDA’s CDER.

For details, see FDA



Posted by Tim Sandle