FDA “Live Review” Inspection of Company Documentation: Are You Ready?

Teresa Gorecki |

The following was included in our July email newsletter. There are many training sessions conducted each year by GMP Training Managers and company quality and compliance staff on “How to Manage an FDA Inspection”. Regularly, FDA inspection management... Read more

FDA Announces New Office of Dietary Supplement Programs (ODSP)

Jack Garvey |

Opportunities and Risks for Dietary Supplement Companies for 2016 and Beyond 2015 is certainly ending with a bang.    As many of us industry insiders have known for some time, FDA has been planning changes to their regulation and... Read more

Executive Insights from FDLI’s 2015 Enforcement, Litigation & Compliance Conference: Trends and Risks for 2016 and Beyond

Jack Garvey |

Early December is one of my favorite times of year. Coming off of Thanksgiving and looking forward to the end-of-year holidays, it’s when I get to reflect on the past 12 months, and think about what the next... Read more