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# CDER Risk, Safety Report for 2022 Issued
- URL: https://www.fdaweb.com/cder-risk-safety-report-for-2022-issued/
- Published: 2023-05-31T12:00:00.000Z
- Updated: 2026-09-14T18:35:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154580

CDER Office of Surveillance and Epidemiology (OSE) director **Gerald Dal Pan** says that in 2022 OSE responded to the Covid-19 and opioid public health emergencies and also detected and assessed risk across all of the drugs that CDER regulates. The OSE [annual report](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDEsInVyaSI6ImJwMjpjbGljayIsInVybCI6Imh0dHBzOi8vd3d3LmZkYS5nb3YvbWVkaWEvMTY4NjM0L2Rvd25sb2FkP3V0bV9tZWRpdW09ZW1haWwmdXRtX3NvdXJjZT1nb3ZkZWxpdmVyeSIsImJ1bGxldGluX2lkIjoiMjAyMzA1MzEuNzc1MDc2MzEifQ.iRgL41eiUvl4Zxn8-LEUiy0Ubr%5FHCIsAVu4h2IB5EGQ/s/1255720147/br/203939094346-l?ref=fdaweb.com) says the risk detection and assessment used the FDA Adverse Event Reporting System database, the Sentinel system, and other sources of drug safety information.

“Our lifecycle approach to preventing risks relies on our well-established medication error prevention program, which includes premarket reviews of proposed proprietary names, human factors analyses for drug-device combination products, review of carton and container labeling and instructions for use, along with postmarket surveillance to detect medication errors,” Dal Pan writes. “Our risk management program, which centers around the review of proposed risk evaluation and mitigation strategies (REMS) and modifications to these programs, took a big step forward in improving the efficiency of REMS review by requiring REMS documents for new REMS and REMS modifications to be submitted electronically in structured product labeling format.”

Dal Pan further says that drug safety modernization and innovation was also a big theme in 2022.