Compliance on a Budget: Can it be Done? What are the Risks?

Jack Garvey |

Like a lot of people, when I was a younger, I always wanted the newest toy or the shiniest item in the store.    An unfortunate reality of growing up is that as we become adults, we come to... Read more

Outsourcing and Offshoring in a New Era of FDA Enforcement

Jack Garvey |

On Thursday, March 11, 2010, Jack Garvey, Principal, Compliance Architects LLC, will be presenting an audio conference in conjunction with FXTranslations  and FXConferences entitled "Outsourcing and Offshoring in a New Era of FDA Enforcement."    This audio conference will... Read more

Regulatory Alert: New FDA Proposed Rule — Sponsor Reporting of Falsified Data

Jack Garvey |

Today the FDA has published a proposed rule in the Federal Register (75 FR 33 at 7412, 2/19/10) that will require sponsors (and defining petitioners under food/supplement submission rules as sponsors) to report to FDA any instance of... Read more