Galena BioPharma Inc – FDA Warning Letter, Nov 21, 2014

The FDA inspected Galena Biopharma, Inc. from November 17-21, 2014, focusing on Postmarketing Adverse Drug Experience (PADE) reporting for Abstral and Zuplenz. The inspection revealed serious violations of PADE reporting requirements under section 505(k) of the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 314.80.

Specific violations include: 1. **Failure to develop adequate written procedures for PADE surveillance, receipt, evaluation, and reporting (21 CFR 314.80(b)).** Draft and revised SOPs were inadequate, lacking details on how ADE information from a contracted call center is retrieved and ensured complete, how ADEs from product complaints are forwarded to pharmacovigilance, and how 15-day Alert reports are followed up and reported. Procedures for timely periodic reporting (PADERs/PSURs) were also insufficient. 2. **Failure to report adverse drug experiences at quarterly intervals (21 CFR 314.80(c)(2)(i)).** Galena Biopharma failed to submit PADERs with Individual Case Safety Reports (ICSRs) for Abstral for multiple quarterly periods from May 2013 to January 2014, despite at least nineteen ADEs being reported. While a PSUR was submitted later, the IC