Placeholder Banner

BIO Submits Comments on FDA Manufacturing, Supply Chain, and Inspections Guidances & Report

July 16, 2021

On Wednesday, July 14th, BIO submitted comments on FDA’s Guidances: 1) Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency Guidance; 2) Updated Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency: Questions and Answers; and the 3) Resiliency Roadmap for FDA Inspectional Oversight Report. In the updated Manufacturing, Supply Chain, and Inspections Questions & Answers document, BIO stated its appreciation for the clear statement in the Q&A Guidance that if a needed inspection cannot be completed due to travel restrictions but there are no other deficiencies (site/facility or otherwise in the application), FDA will defer action, rather than issuing a CRL. In terms of remote evaluations of bioresearch monitoring facilities, BIO proposed that many of the concepts introduced should be retained after the public health emergency ends and become another set of tools in FDA’s toolbox for inspectional activities, utilizing a risk-based approach. Furthermore, we emphasized that this approach could be used in the future to better distribute FDA resources for inspections, ensuring that the majority of staff time is focused on places where in-person assessment is truly needed, and information cannot be obtained via another method. Lastly, BIO requested additional detail regarding how FDA is utilizing the tools and robust dataset in its Resiliency Roadmap to address the inspectional backlog created by the COVID-19 public health emergency; how these tools fit into the larger inspectional paradigm; how remaining inspections will be prioritized; and estimates regarding the resolution of the current and additional backlog would be helpful.

Download Full Comments Below
BIO Comments on FDA COVID Inspections Guidances
Discover More
On Thursday, June 10th, 2021, the U.S. Food and Drug Administration (FDA) published a draft guidance, Core Patient-Reported Clinical Outcomes in Cancer Clinical Trials, providing recommendations to sponsors on the collection of a core set of patient…
The Biotechnology Innovation Organization (BIO) is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30…
As you prepare for Chancellor Merkel’s visit to Washington, we, the representatives of America’s biotechnology sector thought that you and your government might benefit from an update on all that our sector is doing globally to address the ongoing…