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- When was the Biologics Control Act which served as the foundation for regulatory approval of biological products enacted?
- When was insulin first approved for the treatment of diabetes?
- The Food, Drug and Cosmetic Act allowed FDA to inspect facilities, and brought insulin under FDA jurisdiction. When was it enacted?
- When were the first products extracted from cell culture approved?
- When was the first recombinant product approved?
- What was that product?
- Prior to 1962, drugs were regulated based mainly upon their safety. The Kefauver-Harris Amendment in 1962 called attention to the concept of what?
- The Biologics License Application (BLA) was introduced when?
- This 1997 Act sought to minimize the differences between how biologics and other drugs were regulated. What was its name?
- What is the name of the 21st century initiative aimed at accelerating drugs time to market?
How did you do?
9-10: Regulatory Geek
5-6: In Need of Inspection
3-4: Youre Under Consent Decree
0-2: Blissfully Ignorant!