Pharma – Featured

The Ultimate Guide to Researching Your FDA Inspector

The trick with any FDA inspection preparedness program is to reduce the risk of surprise by understanding FDA history and tendencies. But like most professionals in this industry, you’re probably busy with a million things on your to-do list.  And while you know you should set up a complete FDA inspection preparedness program, you just don’t have the time or [...]

The End of Homeopathic Products’ Free Pass

Homeopathic Products:  What Are They and Why Should You Care? Among the unique enforcement actions in fiscal year 2017 are a cluster of warning letters and recalls of homeopathic products.  2017 saw as many warning letters issued to these firms as were issued between 2009 and 2013.  This is a marked change from previous years beginning in 2009 with one warning [...]

Deep Pockets | Does the FDA Get Tougher if the Owner Gets Richer?

Acquisition of one pharmaceutical firm by another is preceded by due diligence efforts in many functional areas.  Let’s talk about activities in the GMP area.  Firms may not be able to fully rely on past inspections by the FDA to predict the extent of remediation that might be necessary in the manufacturing and testing of the firm’s products.  We provide [...]