White Papers

White Papers

Understanding the CDRH Reorganization and Its Potential Impact on Premarket Submission Reviews: Frequently Asked Questions & What You Need to Know

By: Samie Allen, MBA and Joshua Crist, MSE

It can be hard to keep up with the rapid pace of changes in FDA’s regulations and review policies for medical devices. One area that changes roughly every 5 years in some capacity is the organizational structure of..

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...

Regulatory Strategy for Pre-IND Meetings with FDA: Why Meet & What to Ask

By: Ronald A. Salerno, PhD, Kerin Ablashi, MS, Debra Barngrover, PhD, RAC and Kelly Reich MS, RAC

In this paper, the authors call upon their years of experience preparing meeting requests and meeting packages, participating in pre-IND meetings, and reviewing and responding to pre-IND meeting comments from the FDA in order to provide recommendations to organizations looking to make the most out of their pre-IND meeting with FDA.

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.