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# CDER Increases Remote Regulatory Assessments
- URL: https://www.fdaweb.com/cder-increases-remote-regulatory-assessments/
- Published: 2020-12-18T12:00:00.000Z
- Updated: 2026-09-14T16:40:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148342

FDA is continuing to explore using “remote regulatory assessments” in lieu of conducting physical facility inspections during the Covid-19 public health emergency, according to CDER Office of Compliance director **Donald Ashley**. Speaking during a virtual Food and Drug Law Institute conference 12/16, Ashley discussed how CDER has adapted to the changing times by increasing its use of alternative tools to conduct oversight and take regulatory actions, such as sampling of drugs, relying on information shared by its foreign regulatory partners, requesting records and other information from drug manufacturers, clinical investigators and any other parties that are normally subject to inspection, and remote regulatory assessments.

Ashley said that the drug compounding compliance program is developing a pilot program to conduct remote record assessments and help continue oversight of outsourcing facilities during the pandemic. And the bioresearch monitoring program has also been very active in this space, and they've already conducted 17 remote regulatory assessments since the start of this fiscal year (10/1), he said, adding that “we're also exploring ways to provide more transparency regarding our use of the remote regulatory assessments.”

To illustrate the changing regulatory environment, Ashley reflected on pre-pandemic drug adulteration regulatory actions which were based on FDA inspection findings. “As a result of a pandemic we've shifted to these other tools (analytical sample testing) that I've mentioned to serve as the basis of our adulteration compliance actions,” he told the conference attendees. He said that a new import alert (No. [66-78](https://www.accessdata.fda.gov/cms%5Fia/importalert%5F1166.html?ref=fdaweb.com)) was established for analytical sample testing failures. FDA is also issuing more Warning Letters based on analytical sample testing, and there has been an increase in Section [704(a)(4) record requests](https://www.fda.gov/media/86328/download?ref=fdaweb.com). “Now, I anticipate that for the remainder of this fiscal year, that a large percentage and who knows, perhaps the majority of adulteration regulatory actions will continue to be based upon these alternative tools, rather than FDA inspections.

During his presentation, Ashley also raised CDER concerns with *clinicaltrials.gov* compliance, specifically registration and the results reporting requirements. He said FDA has begun to increase “pre-notice of nonompliance letters,” which are not official enforcement actions and the letters are not made public. “If FDA determines that a responsible party has not come into compliance after receiving a pre-notice letter, we will then move to actually issue a notice of noncompliance, which is a public notice, and if the responsible party still doesn't come into compliance FDA may then consider pursuing civil monetary penalties,” he said. “So we're identifying violations through evidence collected during inspections conducted as part of FDA bioresearch monitoring program, and also identifying violations based on an evaluation of complaints that we receive. And we're also developing our own risk-based surveillance methodologies to identify potential non compliance.” To date, these surveillance efforts have led to the issuance of more than 30 pre-notice of non compliance letters.