Revance Therapeutics Inc (RVNC)

[mouton29]

Speaking of inspections...

Here is the first half of a Bloomberg article:

Pandemic disruptions severely hampered U.S. regulators’ ability to inspect drug and device makers’ manufacturing plants, delaying at least 68 applications for approval to market new products, according to a Food and Drug Administration review.

Seven of the delayed applications were mission-critical, meaning they represented a medical advancement, the agency said Wednesday in its report, and six of those were for new drugs. The delayed applications were among 600 where the FDA required a factory inspection before approval decisions.

Inspection woes at the agency have left health investors nervous about clearances of new drugs and devices that impact companies’ bottom lines. Hobbled by travel and social-distancing restrictions during the height of the pandemic, the agency is slowly regaining the ability to conduct mostly domestic inspections and may make increasing use of virtual factory visits to fill the void, Acting FDA Commissioner Janet Woodcock said.

Drug Hearing
Janet Woodcock

“Our report shows all the warts, here’s what happened during the pandemic, but we did a lot,” she said in an interview. “I think our people really rose to the occasion.”

Inspections for the seven delayed mission-critical applications are expected to be completed by the end of September, according to the report. FDA didn’t give the names of the delayed products.

The regulator also will have to find ways to make up about 1,000 routine surveillance inspections of drug and biologic plants it hasn’t been able to perform during the fiscal year that started in October. These inspections insure quality of products that have already been cleared. ....

https://www.bloomberg.com/news/articles/2021-05-05/pandemic-delayed-some-fda-plant-inspections-product-approvals

I looked briefly for the FDA report, no success.