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# CDER Drug Value Assessment Initiatives
- URL: https://www.fdaweb.com/cder-drug-value-assessment-initiatives/
- Published: 2017-02-28T12:00:00.000Z
- Updated: 2026-09-14T22:08:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138090

CDER officials say the Center has two initiatives intended to improve its ability to conduct benefit/risk assessments of new drugs. Writing in the International Society for Pharmacoeconomics and Outcomes Research [journal](https://www.ncbi.nlm.nih.gov/pubmed/28237213?ref=fdaweb.com), CDER director **Janet Woodcock** and Office of the Commissioner staffer **Kathleen Miller** say the initiatives include patient-focused drug development and transparency in the CDER decision-making process. They note that the Center has no legal authority to consider price in its determination of the approval or non-approval of a drug for sale and so regulatory value assessment, an analysis of the trade-off between benefit and risk, is always made independent of price.

CDER defines risk, the article says, as the intersection of the severity of potential harm and the probability of that harm, while benefits are typically quantified directly as a measure of efficacy.

“When the natural history of a disease is well understood,” the two write, “assessing this benefit-risk trade-off can be straightforward. Nevertheless, this is not always the case, and oftentimes a decision must be made on the basis of the evidence and clinical judgment. CDER is working toward minimizing these situations by actively engaging patients in the drug development and regulatory process, and by increasing the transparency in the CDER decision-making process. These difficult assessments will continue, however, until scientific knowledge of disease mechanisms and translational science increases substantially.”