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# CDER Policy on Drug Proprietary Name Reviews
- URL: https://www.fdaweb.com/cder-policy-on-drug-proprietary-name-reviews/
- Published: 2016-01-08T12:00:00.000Z
- Updated: 2026-09-15T02:26:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134385

> CDER has posted a revised internal procedure document on handling requests for drug proprietary name reviews. The document is required as part of FDA’s and the drug industry’s user fee agreement. To meet the review performance goals, a decision about a request for a proposed proprietary name submitted during the IND phase must be communicated to an application holder within 180 days after receiving a request, the [document](http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM182730.pdf?ref=fdaweb.com) says. “For a proposed proprietary name submitted with an NDA/BLA or as part of a supplemental application, a review must be completed and a decision must be communicated to the applicant within 90 days of the receipt of the request to meet the review performance goals,” it says.  
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> Under the policy, CDER’s Office of Surveillance and Epidemiology (OSE) will manage the submissions for proposed proprietary names. OSE will lead an interdisciplinary review team, including the Office of new Drugs, Office of Prescription Drug Promotion, and other CDER offices, as relevant, in reviewing proposed proprietary names, the document says. “OSE will ensure that discussions and decisions for review of proprietary name requests will be made in accordance with CDER’s policy on equal voice, differing professional opinions, and, if necessary, dispute resolution.” it says.