Across
- 3. Historical term for prescription medications that have the phrase “Rx Only” or cautionary text on their labels
- 5. A product that contains false or misleading information
- 7. Test required for generic approval
- 8. Medical products reporting program
- 9. Market failure when your choices create consequences for someone who did not RSVP to the situation
- 13. Type of review that is promised for therapies that treat a serious or life-threatening condition and provide therapeutic benefit over available therapies
- 15. reviewing drug application taking 10 months (2 words, no spaces)
Down
- 1. A listing of all FDA approved drug products (2 words, no spaces)
- 2. The fancy ethics term behind, “first, do no harm”
- 4. Teratogenic European sedative whose severe safety concerns spurred the 1962 Kefauver-Harris Amendment
- 6. Packaging to make a toddler say, “fine I give up” (2 words, no space)
- 10. Type of new drug application that is generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness
- 11. prohibited act under 21 USC 351 that deals with defects in product strength, purity, quality or unsanitary manufacturing conditions
- 12. initial safety test
- 14. Submitted by sponsor for new drug approval