Jack Garvey |

Two months ago I posted in LinkedIn about a Popular Science article that unfairly characterized FDA’s regulatory process, and implied FDA tacitly agreed with a company’s characterization of what can best be considered a sham product as a... Read more

Trump, Regulatory Reform & FDA Compliance: The Impact of the US Election on FDA Regulatory Enforcement

Jack Garvey |

The election of Donald Trump as President-Elect of the United States was, and continues to be, a watershed moment in the 200+ year American experiment.   The public, the business community, and government are all currently adjusting to a... Read more

Quality Agreements – Cornerstone of Product Supply Relationships

Teresa Gorecki |

I worked for a Chief Quality Officer a number of years ago who always had this response when our company was contemplating movement of a large volume of internal production to third parties: “You can delegate your responsibilities... Read more