FDA Flashcards
(3 cards)
1
Q
Food, drug and cosmetic act
A
Guidelines for efficacy and safety. Requires toxicity studies and multi step approach for medication to be approved for mass market.
2
Q
FDA preventing drug abuse
A
Harrison Narcotics Act- Schedule of drugs
State Rx monitoring programs, assessment of new products for abuse potential.
3
Q
FDA Adverse Effect Monitoring
A
Online portal- report Rx or OTC, biologics, med. devices. nutritional supplements, cosmetics, foods and beverages