FDA Gets Until May 16 to File PMTA Reports

Courtesy: US FDA

UPDATE: The order has been granted. First reports are due May 16.

The U.S. Food and Drug Administration is asking the U.S. District Court of Maryland for a 14-day extension to file the first status report required by the Court’s revised remedial order.

The plaintiffs in the case consent to the requested extension, according to the motion filed today.

“The extension request is supported by good cause. Compiling the information needed for the status report has required considerable time and effort, and Defendants have been working with
Plaintiffs to resolve any ambiguities about which applications will be covered in the status report,” the motion states. “Also, a number of FDA employees helping to prepare the status report were out of the office on pre-planned leave last week, and a key FDA employee responsible for the status report will be out of the country on pre-planned leave next week.

“Defendants do not seek to modify any other deadline, and the FDA’s second status report would remain due July 28, 2022. Defendants are prepared to have this letter serve as their consent motion for a 14-day extension.”

Judge Grimm is expected to grant the motion’s request. The new deadline for first PMTA status reports would be May 16 if motion is granted.