White Papers

White Papers

Meeting Report: Vaccine Stability Considerations to Enable Rapid Development and Deployment

By: Mark Alasandro, Dilip Choudhury, Kim Huynh, Jianmei Kochling, Christopher Latoz, Laure Larkin, Lori McCaig, Nanda Subbarao, Yan Wu and Yajie Zhang

The Stability Community of the American Association of Pharmaceutical Scientists (AAPS) held a virtual workshop on “Vaccine Stability Considerations to Enable Rapid Development and Deployment”, on March 24-25, 2021. The workshop included distinguished speakers and panelists from across the industry, academia, regulatory agencies, as well as health care leaders. This paper presents a review of […]

Overview of FDA Timelines Associated with Traditional 510(k)s

By: Becky Ditty, MS

The Medical Device User Fee Act (MDUFMA) I, signed into law on October 26, 2002, authorized FDA to collect user fees for various marketing applications, including premarket notifications (510(k)s). The fees...

Breakthrough Designation: Is it the path for your device?

By: Christy Foreman, MBE and Becky Ditty, MS

You are working on creating a novel new device. It is an exciting time! But with novelty comes many unanswered questions, including what is the best regulatory pathway. The Breakthrough Device Program may be a part of that pathway.

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.