Pharma/biopharma manufacturer/developer Accorda Therapeutics received a Warning Letter on May 9 after an inspection between August 15, 2011 and September 9, 2011 revealed inadequacies in the firm’s adverse event handling procedures. Major issues in the WL are:
- Failure to submit all adverse drug experiences (ADEs) that are both serious and unexpected to FDA within 15 calendar days of initial receipt of the information as required by 21 CFR 314.80(c)(1)(i)
- Failure to develop adequate written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences (ADEs) from all sources as required by 21 CFR 314.80(b)
- Failure to maintain records of all adverse drug experiences known to you, including raw data and any correspondence relating to adverse drug experiences, for a period of 10 years as required by 21 CFR 314.80(i)
- Failure to report each adverse drug experience not reported under 21 CFR 314.80(c)(1)(i) at quarterly intervals as required by 21 CFR 314.80(c)(2)(i).