Registration

PDUFA Pilot Project Proprietary Name Review

Notice of Intent reporting requirements

Registration

OMB: 0910-0648

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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

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