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...
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.
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.