FDA Issues Q&A Guidance on Inspections, Drug Applications During Pandemic

The FDA has released a question-and-answer guidance to clarify its policies on inspections, pending drug applications and changes in manufacturing facilities for approved drug products during the COVID-19 pandemic.

As of July 20, the agency has resumed conducting “mission-critical” inspections and is using a rating system to determine, based on geographical region, where it can safely resume prioritized domestic inspections.

For the foreseeable future, the prioritized domestic inspections will be pre-announced to allow for proper safety measures and ensure the appropriate staff are present during the inspection, the agency said.

Foreign pre-approval and for-cause inspections not seen as mission-critical remain on hold, but those considered essential will be decided on a case-by-case basis, the agency said.

“During this interim period, FDA is using additional tools, where available, to determine the need for an inspection and to support the application assessment, such as reviewing a firm’s previous compliance history, using information sharing from trusted foreign regulatory partners through mutual recognition and confidentiality agreements, and requesting records ‘in advance of or in lieu of’ facility inspections or voluntarily from facilities and sites,” the FDA said.

To identify “mission-critical” inspections, the agency said it weighs both domestic and foreign inspections based on the importance of the product for public health. Factors the agency considers include whether the products have been given a Breakthrough Therapy designation or Regenerative Medicine Advanced Therapy designation or are indicated for a serious disease or medical condition and have no substitutes.

The agency also clarified that applications will not automatically receive a Complete Response Letter (CRL) when an inspection cannot be conducted. If the agency determines that an inspection is needed before approval because available information raises concerns about the facility, it will tell the applicant as soon as possible during the review cycle. If the facility has not been inspected by the agency’s action date, a CRL will generally be issued. However, if there is not enough information to determine a facility’s acceptability, action may be deferred on the application until an inspection can be carried out, the guidance said.

The agency said comments can be submitted on the final guidance at any time.

Read the full guidance here: www.fdanews.com/08-19-20-COVID19ManufacturingInspectionsQA.pdf. — James Miessler