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  5. Manufacturing, Supply Chain, and Drug Inspections | COVID-19
  1. Coronavirus (COVID-19) | Drugs

Manufacturing, Supply Chain, and Drug Inspections | COVID-19

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 FDA has guidance on how to implement manufacturing process and facility changes, and the process for reporting these types of changes to the application in the references below.


Inspections Q&A

FDA issued a temporary guidance for industry entitled, “Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers.”  FDA recognizes the COVID-19 public health emergency is not only impacting public health, but also drug development programs, ongoing manufacturing operations, and FDA’s ability to conduct inspections.  The agency also recognizes sponsors and applicants have many questions related to FDA inspections.  FDA developed this guidance to provide answers to a number of frequently asked questions.

The Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Office of Regulatory Affairs remain fully capable of continuing daily activities, such as application assessments, including facility evaluation and certain inspection activities, while responding to public health needs related to the current COVID-19 public health emergency. As this remains an evolving and very dynamic situation, FDA will continue to be flexible and transparent. The questions and answers in this guidance provide information regarding common questions related to inspections for facilities manufacturing pharmaceutical products and sites involved in the conduct of clinical, analytical and nonclinical studies.


Contact Us

For additional questions about manufacturing changes, please email CDER-OPQ-Inquiries@fda.hhs.gov. Please include “COVID-19 inquiry” in the subject line of the email.


References

 

More information on Coronavirus (COVID-19) | Drugs

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