Dec 1, 2015 | Uncategorized
FDA released three significant FSMA final rules last month, on foreign supplier verification, produce and accreditation of third-party auditors – all formally published in the Federal Register on November 27. Each of these three significant rules deserve separate...
Dec 1, 2015 | Issue of the Month
By Albert Yehaskel Completing a successful electronic Common Technical Document (eCTD) submission can be daunting, even with the help of guidance documents from the International Conference on Harmonization (ICH) – which developed the eCTD – or from...