• Skip to primary navigation
  • Skip to main content
  • Skip to footer

Human Research Protection Program

University of Southern CaliforniaResearch and Innovation
  • Getting Started
  • Research
  • HRPP
  • IRB
  • Education & Certification
  • Policies
  • Contact
You are here: Home / Policies / FDA Regulations

FDA Regulations

The Food and Drug Administration (FDA) “is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.”

Research studies involving human subjects must comply with federal regulations. The Code of Federal Regulations (CFR) Title 21 CFR is specific to rules and regulations of the FDA. Regulations pertaining to human subjects research include:

  • Protection of Human Subjects (21CFR§50)
  • Financial Disclosure by Clinical Investigators (21CFR§54)
  • Institutional Review Boards (21CFR§56)
  • Investigational New Drug (21CFR§312)
  • Biological Products (21CFR§600)
  • Investigational Device Exemptions (21CFR§812)

FDA Resources

Searchable Database for Federal Regulations (Title 21)
FDA Guidance Documents
FDA Information Sheets
FDA on Financial Disclosures
Exception from Informed Consent Requirements for Emergency Research
Information for Health Professionals

Investigational New Drug (IND)

Center for Drug Evaluation and Research (CDER)
Sponsor-Investigators Submitting Investigational New Drug Applications

Investigational Device Exception (IDE)

Center for Devices and Radiological Health (CDRH)
Clinical Trials and Investigational Device Exemption

Biologics

Center for Biologics Evaluation and Research (CBER)
Submitting an Investigational New Drug Application for a Biological Product

Footer

HRPP

3720 S. Flower Street, Suite 325
Los Angeles, CA 90089

HRPP@usc.edu
(323) 442-0114

Full Accreditation badge from the Association for the Accreditation of Human Research Protection Programs

About Us

  • Home
  • Announcements
  • Contact
  • Getting Started
  • Education & Certification
  • HRPP
  • Policies
  • Twitter

Research

  • BioIRB Meeting Dates
  • BioIRB Rosters
  • Biomedical Research
  • Biospecimen & Data Repositories
  • Emergency Research
  • Investigational Drugs and Devices
  • Investigator-Initiated Trials
  • Reliance Agreements
  • Requesting USC IRB to Act as the sIRB
  • Requesting USC to Rely on an External IRB
  • SBIRB Meeting Dates
  • SBIRB Roster
  • SBIRB Social Behavioral Research
  • Starting a Research Trial: the Basics
  • Student Researchers

IRB

  • Forms and Templates
  • FWA and IRB Registration Numbers
  • IRB FAQs
  • IRB Review: How to
  • IRB Submission Guidelines
  • Levels of IRB Review
  • Not Human Subjects Research (NHSR)
  • Privacy, Confidentiality, and Anonymity in Human Subjects Research
  • Recruitment Guidance
  • Urgent Review

HRPP
3720 S. Flower Street, Suite 325
Los Angeles, CA 90089
oprs@usc.edu
irb@usc.edu
(323) 442-0114

Full Accreditation badge from the Association for the Accreditation of Human Research Protection Programs
University of Southern California   Content managed by HRPP
  • Privacy Notice - Notice of Non-Discrimination