Understanding the Clinical Trial Process for Drugs and Biologics

September 18, 2014 10:30am


David G. Adams
Venable LLP

Daniel A. Kracov
Arnold & Porter LLP

  • Outlining the phases of clinical trials (I-IV)
  • Regulatory requirements (e.g., informed consent, IRBs, sponsor obligations, investigator obligations, etc.)
  • FDA authority
  • Discussing the roles and obligations surrounding CROs and SMOs
  • Identifying major differences between clinical trials for drugs and biologics
  • Disclosure of clinical trial information
    • FDA Amendments Act of 2007
    • FDAMA § 113
    • clinicaltrials.gov
    • PhRMA policies