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U.S. Department of Health and Human Services

Drugs

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How Does an RDRC Obtain FDA Approval?

[§ 361.1(c)(4)]

Submit an Application

  1. Complete FDA 2914 including:
    • the names and qualifications of the RDRC members and consultants [§ 361.1(c)(4)]
    • a statement that the RDRC agrees to comply with the requirements set forth in § 361.1. [§ 361.1(c)(4)]
  2. We recommend that you attached a current curriculum vitae (CV) (dated) for each RDRC member and consultant.  Each CV should include the specific qualifications and experience that meet the requirements of membership (see What are the Qualifications and Requirements of RDRC Membership?)
  3. Submit the completed application form and CVs to the following address:

Food and Drug Administration

Center for Drug Evaluation and Research

Office of Drug Evaluation IV
5901-B Ammendale Road
Beltsville, MD 20705-1266

Attention: RDRC

Approval by FDA

  1. FDA will review the RDRC application and, if acceptable, issue an approval letter to the RDRC chairperson. Approval is based upon a positive assessment of the qualifications of the members of the RDRC and the assurance that all necessary fields of expertise are covered [§ 361.1(c)(4)] (see What are the Qualifications and Requirements of RDRC Membership?).
  2. A RDRC must obtain FDA approval before it may approve research studies under 21 CFR 361.1 [§ 361.1(b)(1)]. Approval of a RDRC will remain in effect unless and until FDA withdraws such approval.  Approval of a RDRC may be withdrawn at any time for failure of the RDRC to comply with the requirements of § 361.1 [§ 361.1(c)(4)].