Notice of Intent: Reporting Requirements
For proposed proprietary names that are being submitted as part of an IND, NDA, BLA, ANDA, or supplement reviewed by CDER, contact Carol Holquist by e-mail at proprietarynamereview@fda.hhs.gov. Applicants should provide the following information in the e-mail for registration:
E-mail subject heading: “PNR Pilot Program for CDER/DMEPA”
First sentence in e-mail should indicate: “Request for Registration in PNR Pilot Program”
Company name
Name of U.S. regulatory contact (include telephone number and e-mail address)
Name of entity conducting proprietary name analysis (applicant company or third-party vendor)
Application type (IND, NDA, BLA, ANDA, or supplement) and application number
Proposed proprietary name (identify primary and alternate proprietary name, if any)
Approximate (requested) month for intended submission
| File Type | application/msword |
| File Modified | 2009-09-24 |
| File Created | 2009-09-24 |