Embracing “Quality” Over “Compliance” — A Misguided Approach to Improving FDA-Regulated Quality Outcomes
As someone with many years of experience working in and around FDA-regulated manufacturing operations, a recent LinkedIn post (March 2018) entitled “Why QUALITY Needs to STOP Working on COMPLIANCE” has really rankled me. Unfortunately, this is not the... Read more
Akorn, Fresenius and Data Integrity – A Journey from ALCOA to Materiality and FDA Enforcement Risk
The following is a redacted transcript of a live, conference call question and answer session conducted on 16 March 2018 with a leading investment advisory firm interested in the Akorn v. Fresenius merger litigation. Jack Garvey, CEO of... Read more
US DOJ Reverses Decades of Predictable Guidance to Life Sciences Industry
On January 25, 2018, the United Stated Department of Justice under Attorney General Jeff Sessions reversed decades of accepted regulatory agency practice by substantially reducing the importance and significance of Guidance Documents for not only life sciences companies,... Read more
