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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

 FDA has guidance on how to implement manufacturing and site changes, as well as reporting to the application, listed in references below.


Inspections Q&A

CDER remains fully capable to continue daily activities, such as drug reviews, while responding to the public health needs of the current COVID-19 outbreak.  As this remains an evolving and very dynamic situation, the FDA will continue to be flexible and as transparent as possible.

  • Due to the COVID-19 pandemic, FDA announced that we are temporarily postponing all domestic and foreign routine surveillance facility inspections.  These facility inspections are assigned biannually using a risk-based Site Selection Model.
  • Similarly, routine surveillance inspections in support of the Bioresearch Monitoring (BIMO) program are currently postponed.  Postponed inspections are being prioritized for completion when travel restrictions are lifted. 
  • Where possible, other pathways are being used to inform decisions regarding pending applications including requesting existing inspection reports from other competent authorities, requesting information from applicants, and requesting records from facilities and other inspected entities directly.
  • Pre-approval and for-cause assignments deemed mission-critical will still be considered for inspection on a case-by-case basis.

Manufacturing and Supply Chain Change Requests Q&A

  • If your application is for a drug not related to the treatment of patients with COVID-19 or not on the FDA drug shortage list, please follow the established guidance documents listed below for changing or adding a facility to your application.
  • If your drug application relates to the treatment of patients with COVID-19 or is on FDA's drug shortage list, the cover letter to the submission should clearly state “Priority Review Requested” and include supporting information for the request.
    • If the product could enter, or is currently in, drug shortage, please also contact CDER DRUG SHORTAGES (DrugShortages@fda.hhs.gov)

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

 

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