White Papers

White Papers

Medical Device De Novo Classification Applications: Frequently Asked Questions and What You Need to Know.

By: Miriam Provost, PhD and Samie Allen, MBA

In recent years, the FDA has overhauled the De Novo program to make it simpler and more attractive to medical device manufacturers. One of the areas of focus has been the program for De Novo classifications...

Zika Virus: The Development of Medical Countermeasures

By: Paul W. Price, PhD, Senior Consultant

The global concern about Zika virus continues to grow as the international community braces for its continued spread.

Data Integrity and the Pre-Approval Inspection: An Inspector’s Experience

By: John R. Godshalk, MSE, MBA, Senior Consultant

Data integrity has always played an essential role in regulatory application review and cGMP inspections – a trend that will only continue to grow in the coming years.