Understanding the Clinical Trial Process for Drugs and Biologics
Daniel A. Kracov
Partner
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