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# CDER Compliance Priorities Include Covid, Opioids Focus
- URL: https://www.fdaweb.com/cder-compliance-priorities-include-covid-opioids-focus/
- Published: 2022-04-29T12:00:00.000Z
- Updated: 2026-09-14T17:42:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151714

CDER’s Office of Compliance (OC) says its priorities for 2022 include supporting FDA’s Covid-19 response (supporting new therapy development and protecting the public from harmful and illegal products), reducing harm caused by opioid crisis, and improving the agency’s oversight of drug compounding operations. In a just-released [OC Annual Report](https://www.fda.gov/media/157954/download?utm%5Fmedium=email&utm%5Fsource=govdelivery), the office says it will also implement mandated wholesale drug security enhancements, conduct regulatory and enforcement actions targeting drugs with the greatest potential to cause harm, and conduct outreach and education that focuses on risk-based enforcement and compliance priorities.

During the Covid-19 public health emergency, OC says it has gained new perspectives on the importance of collaborating with its global counterparts. For example, in 2021 CDER’s Office of Scientific Investigations (OSI) shared 54 bioresearch inspection reports and participated in five remote bioresearch inspections with global partners in 2021\. “For the first time ever, we also exclusively used European Medicines Agency inspection information to support the assessment of clinical trial conduct and data reliability for a new drug application,” the report says.

OSI also published an 8/2021 [article](https://ascpt.onlinelibrary.wiley.com/doi/10.1002/cpt.2386?ref=fdaweb.com) in *Clinical Pharmacology and Therapeutics* in collaboration with the UK Medicines and Healthcare Products Regulatory Agency (MHRA) that addresses data integrity topics in response to a 2020 joint Good Clinical Practice symposium that OSI co-hosted with MHRA.

Additionally, the OC report broke down 2021 compliance numbers, such as:

- 149 warning letters issued
- 101 facility inspection classification letters issued
- 26 ClinicalTrials.gov pre-notice of noncompliance letters issued
- 47 bioresearch monitoring remote regulatory assessments conducted
- Assisted in the prevention and mitigation of drug shortages for 59 different medications