Stanford

FDA Submissions – Drugs & Biologics (IND)

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Spectrum serves faculty and clinical research personnel at Stanford School of Medicine, Stanford University Medical Center, Lucile Packard Children's Hospital, and the Veterans Affairs Palo Alto Health Care System.

Services Provided
  • Budget & Billing Support
  • Regulatory/Compliance Support
  • Training & Education
  • Point of Contact for questions about clinical research

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Non-Cancer Studies

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Contact Information

Spectrum
Operations, Training & Compliance
800 Welch Road
MC: 5737
Palo Alto, CA 94304
Fax (650) 723-8552

The U.S. Food and Drug Administration website provides information for the Investigational New Drug (IND) Application. The site includes information and resources including:

  • Pre-IND Consultation Program
  • Guidance Documents for INDs
  • Laws, Regulations, Policies and Procedures
  • Emergency Use of an Investigational Drug or Biologic
  • Related Resources, including Applications

Training

Spectrum works in collaboration with the IRB and the Cancer Clinical Trials Office to provide education and training for investigators and research teams conducting research with INDs and IDEs held by a Stanford investigator.

Next Steps