Important Dates
Food, Drug & Cosmetics Act became effective
What is 1938?
Caused birth defects
What is Thalidomide?
The shortest phase
What is Phase I?
Reviews safety data
Who are the PI and Clinician/Medics?
A new treatment
What is first in class?
1983
What is the Orphan Drug Act?
We started with 600 subjects, only 77 survived
What is the Tuskegee Experiment of 1932?
The longest phase
What is Phase III (or PIV observational)?
Reviews source documents against reported data
Who is the CRA?
A new or better formulation
What is best in class?
The Jungle
What is 1906?
22 children died from this
What is tetanus from contaminated vaccines?
Lab and animal testing only
What is Pre-clinical Research?
Labs, radiology, etc.
Who are specialty providers or niche CROs?
Treats underserved populations
What are Orphan Drugs?
1902
What is the Virus-Toxin Law (Biologics Control Act)
Seven deaths in three days
What are the Tylenol murders?
Collect safety information
What are all phases?
Responsible for an outsourced function or set of tasks
Who are functional service providers?
Extends market exclusivity
What is "Evergreening"?
FDAMA
What is the Food & Drug Administration Act of 1997?
100 Americans died from this
What is the elixir sulfanilamide (diethyl glycol)?
~25-30% of drugs move to the next phase
What is Phase III?
The company accountable for the study
Who is the Sponsor?
Oncology, CNS, & Autoimmune Diseases
What are the indications with the largest market size?