Under DESI, reevaluation focused on drugs approved during which period?

Under DESI, reevaluation focused on drugs approved during which period?

• A. 1950 to 1965
• B. 1920 to 1938
• C. 1938 to 1962
• D. 1970 to 1980

Answer: (C)

DESI targeted drugs approved between 1938 and 1962. The 1938 act required safety, but efficacy wasn’t mandatory until the 1962 Kefauver Harris Amendment. DESI reevaluated these pre-1962 drugs to determine whether they provided real therapeutic benefit and remained suitable for marketing, leading to withdrawal or labeling changes if needed. Drugs approved after 1962 followed the newer approval standards and aren’t part of this reevaluation.

DESI targeted drugs approved between 1938 and 1962. The 1938 act required safety, but efficacy wasn’t mandatory until the 1962 Kefauver Harris Amendment. DESI reevaluated these pre-1962 drugs to determine whether they provided real therapeutic benefit and remained suitable for marketing, leading to withdrawal or labeling changes if needed. Drugs approved after 1962 followed the newer approval standards and aren’t part of this reevaluation.