Embracing “Quality” Over “Compliance” — A Misguided Approach to Improving FDA-Regulated Quality Outcomes

Jack Garvey |

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

US DOJ Reverses Decades of Predictable Guidance to Life Sciences Industry

Jack Garvey |

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

Deputy Assistant US Attorney General Outlines New Approaches for Enforcement of FDA-Regulated Companies

Jack Garvey |

On Thursday, December 7, Deputy Assistant Attorney General Ethan P. Davis, US Department of Justice, Consumer Protection Branch, gave a speech at the Food and Drug Law Institute Enforcement Litigation and Compliance Conference in Washington, DC. In this... Read more