FDA
After completing the clinical trials Phase I-III, the sponsor must dubmit an NDA or BLA. What does NDA stand for?
What is a New Drug Application?
The FDA resposible in regulating public health by assuring ____, ____, and ____.
What is... Safety, Efficacy, and Security
The Phase 3 of clinical trial confirms ___ and ___ in people with the disease.
What is efficacy & safety?
The drug that encourage the development of the Kefauver-Harris Amendment in 1962 (HINT: caused birthdefects in European children)
What is Thalidomide?