Expert Explains How Postpandemic Inspections Could Impact Approvals

Many pre-approval inspections that were in limbo because of the backlog during the pandemic are now going ahead and the uptick could result in more product approvals, according to regulatory attorney Cathy Burgess, a partner in the law firm Alston & Bird.

On the other hand, some long-awaited pre-approval inspections could “reveal facility manufacturing deficiencies that result in complete response letters, and that could slow things down,” Burgess said in an Oct. 26 webinar hosted by FDAnews, a WCG company, titled “FDA in 2024—What to Expect in an Election Year.”

Burgess, who leads Alston & Bird’s FDA compliance and enforcement team, will join an expert panel on day two of the 18th Annual FDA Inspections vSummit, Nov. 8-9, offering tips for dealing with the FDA during an inspection. See details on the virtual inspection summit here.

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