How Well Do You Know FDA? Take Our Regulatory History Quiz

Keith Webber, FDA deputy director for the Office of Pharmaceutical Science, spoke at the recent BIO 2006 show in Chicago, and provided an extensive history of biologics regulation. The following quiz is based upon the information that Webber presented.

By Paul Thomas, Managing Editor

Editor's Note: After completing the quiz, you may scroll down to see the answers and check your score. No peeking!



  1. When was the Biologics Control Act — which served as the foundation for regulatory approval of biological products — enacted?


  2. When was insulin first approved for the treatment of diabetes?


  3. The Food, Drug and Cosmetic Act allowed FDA to inspect facilities, and brought insulin under FDA jurisdiction. When was it enacted?


  4. When were the first products extracted from cell culture approved?


  5. When was the first recombinant product approved?


  6. What was that product?


  7. Prior to 1962, drugs were regulated based mainly upon their safety. The Kefauver-Harris Amendment in 1962 called attention to the concept of what?


  8. The Biologics License Application (BLA) was introduced when?


  9. This 1997 Act sought to minimize the differences between how biologics and other drugs were regulated. What was its name?


  10. What is the name of the 21st century initiative aimed at accelerating drugs’ time to market?

























Answers:

  1. 1902


  2. 1922


  3. 1938


  4. 1943


  5. 1982


  6. Humilin


  7. Efficacy


  8. 1996


  9. FDA Modernization Act


  10. Critical Path Initiative


How did you do?

9-10: Regulatory Geek

7-8: Respectable

5-6: In Need of Inspection

3-4: You’re Under Consent Decree

0-2: Blissfully Ignorant!











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